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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91386

38 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 17, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

38 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 38

ANCILLARY PACK-LF. Sterile Procedural Tray.

Z-1060-2023
Recall number
Z-1060-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
48 cases (96 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ0185290G, Case UDI/GTIN: 40193489378055, Unit UDI/GTIN: 10193489378054, Lot Number: 22HME772;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 2 of 38

TRACH PACK. Sterile Procedural Tray.

Z-1061-2023
Recall number
Z-1061-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
28 cases (112 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ46518G, Case UDI/GTIN: 40195327009169, Unit UDI/GTIN: 10195327009168, Lot Number: 22JMB321, 22JMA904, 22HMD287

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 3 of 38

LOCAL PACK. Sterile Procedural Tray.

Z-1062-2023
Recall number
Z-1062-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
8 cases (200 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ34129C, Case UDI/GTIN: 40889942382300, Unit UDI/GTIN: 10889942382309, Lot Number: 22IBG550

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 4 of 38

Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC

Z-1063-2023
Recall number
Z-1063-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
12 cases (60 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. PAIN SERVICE PACK-LF, Item Number: DYNJ0101290D, Case UDI/GTIN: 40193489345552, Unit UDI/GTIN: 10193489345551, Lot Number: 22HDC372; b. LOCAL BASIC, Item Number: DYNJ34418L, Case UDI/GTIN: 40193489969277, Unit UDI/GTIN: 10193489969276, Lot Number: 22HBQ831, 22HBO949;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 5 of 38

UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray

Z-1064-2023
Recall number
Z-1064-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
20 cases (120 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ52230, Case UDI/GTIN: 40889942252269, Unit UDI/GTIN: 10889942252268, Lot Number: 22IBJ862

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 6 of 38

FEMORAL ARTERY PACK-LF. Sterile Procedural Tray

Z-1065-2023
Recall number
Z-1065-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
15 cases (30 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ0826625Q, Case UDI/GTIN: 40193489377942, Unit UDI/GTIN: 10193489377941, Lot Number: 22KMA163, 22JME722

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 7 of 38

Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO

Z-1066-2023
Recall number
Z-1066-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
314 cases (719 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. CARDIAC CATH PACK-LF, Item Number: DYNJ0368386D, Case UDI/GTIN: 40889942060246, Unit UDI/GTIN: 10889942060245, Lot Number: 22IMD669; b. ANGIOGRAPHY-NS-LF, Item Number: DYNJ24913N, Case UDI/GTIN: 40195327127368, Unit UDI/GTIN: 10195327127367, Lot Number: 22JBC783; c. EP BASIC SET UP PACK, Item Number: DYNJ27920D, Case UDI/GTIN: 40884389855349, Unit UDI/GTIN: 10884389855348, Lot Number: 22IBS859; d. IMPLANT PACK-LF, Item Number: DYNJ43426C, Case UDI/GTIN: 40195327255313, Unit UDI/GTIN: 10195327255312, Lot Number: 22IBO525; e. PORT PACEMAKER INSERTION PACK, Item Number: DYNJ43506A, Case UDI/GTIN: 40888277541000, Unit UDI/GTIN: 10888277541009, Lot Number: 22IBT230; f. OPEN HEART PACK, Item Number: DYNJ43937, Case UDI/GTIN: 40888277077967, Unit UDI/GTIN: 10888277077966, Lot Number: 22HBR302; g. LAP BASIN TRAY, Item Number: DYNJ50908B, Case UDI/GTIN: 40193489997621, Unit UDI/GTIN: 10193489997620, Lot Number: 22JDA804; h. ANGIO ACCESS, Item Number: DYNJ82082, Case UDI/GTIN: 40195327167616, Unit UDI/GTIN: 10195327167615, Lot Number: 22JMA564; i. ANGIO, Item Number: DYNJ905151B, Case UDI/GTIN: 40195327219964, Unit UDI/GTIN: 10195327219963, Lot Number: 22JMG564,22IMG399;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 8 of 38

Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy. VASCULAR PACK zzzzz. OPEN HEART TRAY A-LF aaaaaa. VASCULAR PACK bbbbbb. PACEMAKER PACK cccccc. OPEN HEART PACK dddddd. ENDOVASCULAR PACK-LF eeeeee. VASCULAR PACK-LF ffffff. BASIC OPEN HEART PACK-LF gggggg. OPEN VASCULAR PACK-LF hhhhhh. PK, EP LAB PACEMAKER iiiiii. PK, OPEN HEART-CABG jjjjjj. OPEN HEART PACK kkkkkk. PK, OPEN HEART- A&B llllll. SVMMC VASCULAR MAJOR PACK mmmmmm. CV PACK nnnnnn. OPEN HEART PACK A AND B oooooo. SVMMC CAROTID PACK pppppp. PK, OPEN HEART-CABG A&B qqqqqq. PK, OPEN HEART-A&B rrrrrr. VASCULAR PACK ssssss. PK, OPEN HEART tttttt. PK, OPEN HEART uuuuuu. OPEN HEART PACK vvvvvv. PK, OPEN HEART-A&B wwwwww. OPEN HEART PACK xxxxxx. PK, OPEN HEART-CABG yyyyyy. PK, OPEN HEART zzzzzz. CASTRO CABG-COMPONENT PACK aaaaaaa. RE-ENTRY PACK bbbbbbb. HEART PACK ccccccc. OPEN HEART SUPPLY PACK ddddddd. PK, OPEN HEART-CABG eeeeeee. CABG PROCEDURE PACK fffffff. CABG PACK ggggggg. PK, OPEN HEART hhhhhhh. VASCULAR GRAFT PACK iiiiiii. PK, OPEN HEART jjjjjjj. VASCULAR PACK kkkkkkk. PK,

Z-1067-2023
Recall number
Z-1067-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
12,964 cases (23,379 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. EP LAB PACEMAKER PACK, Item Number: 00-401893L, Case UDI/GTIN: 40195327127887, Unit UDI/GTIN: 10195327127886, Lot Number: 22JMC769; b. OPEN HEART CDS, Item Number: CDS840016AD, Case UDI/GTIN: 40193489741842, Unit UDI/GTIN: 10193489741841, Lot Number: 22KBB889; c. OPEN HEART CDS, Item Number: CDS840023T, Case UDI/GTIN: 40193489682060, Unit UDI/GTIN: 10193489682069, Lot Number: 22JBU353,22JBT770; d. AAA CDS, Item Number: CDS840076AC, Case UDI/GTIN: 40195327209620, Unit UDI/GTIN: 10195327209629, Lot Number: 22KBE518; e. OPEN HEART CDS, Item Number: CDS840094N, Case UDI/GTIN: 40195327089512, Unit UDI/GTIN: 10195327089511, Lot Number: 22JBI258,22IBF817; f. PACEMAKER CDS, Item Number: CDS840162V, Case UDI/GTIN: 40193489480628, Unit UDI/GTIN: 10193489480627, Lot Number: 22KBG388,22IBP339; g. HEART CDS, Item Number: CDS840179M, Case UDI/GTIN: 40889942894001, Unit UDI/GTIN: 10889942894000, Lot Number: 22JBJ710,22IBQ944; h. VALVE PACK, Item Number: CDS840187T, Case UDI/GTIN: 40193489816465, Unit UDI/GTIN: 10193489816464, Lot Number: 22JMG653; i. OPEN HEART CDS-3, Item Number: CDS840246N, Case UDI/GTIN: 40889942217428, Unit UDI/GTIN: 10889942217427, Lot Number: 22JLB009,22JLA126,22ILB075; j. OPEN HEART PACK, Item Number: CDS840332Y, Case UDI/GTIN: 40195327259298, Unit UDI/GTIN: 10195327259297, Lot Number: 22KLA079; k. OPEN HEART PACK, Item Number: CDS840393M, Case UDI/GTIN: 40195327188543, Unit UDI/GTIN: 10195327188542, Lot Number: 22KBD842; l. OPEN HEART ADULT, Item Number: CDS840396X, Case UDI/GTIN: 40193489461917, Unit UDI/GTIN: 10193489461916, Lot Number: 22JBG072,22JBG077,22JBG079; m. OPEN HEART CDS PART A, Item Number: CDS840402AG, Case UDI/GTIN: 40195327255115, Unit UDI/GTIN: 10195327255114, Lot Number: 22JLA474; n. GLENNON OPEN HEART CDS, Item Number: CDS840412N, Case UDI/GTIN: 40195327072231, Unit UDI/GTIN: 10195327072230, Lot Number: 22JBG206; o. OPEN HEART CDS, Item Number: CDS840483K, Case UDI/GTIN: 40888277749796, Unit UDI/GTIN: 10888277749795, Lot Number: 22IBR228; p. MEMORIAL MED CTR BYPASS, Item Number: CDS901660, Case UDI/GTIN: 40888277814111, Unit UDI/GTIN: 10888277814110, Lot Number: 22KBA999,22JBL553; q. OPEN HEART PEDS, Item Number: CDS981050Q, Case UDI/GTIN: 40889942864660, Unit UDI/GTIN: 10889942864669, Lot Number: 22JBH010,22IBC746,22IBC748; r. OPEN HEART CDS-4, Item Number: CDS981159J, Case UDI/GTIN: 40889942215110, Unit UDI/GTIN: 10889942215119, Lot Number: 22JLA895,22ILA228; s. OPEN HEART, Item Number: CDS981161AB, Case UDI/GTIN: 40193489817462, Unit UDI/GTIN: 10193489817461, Lot Number: 22JBT785; t. CAB CDS, Item Number: CDS981533G, Case UDI/GTIN: 40195327171422, Unit UDI/GTIN: 10195327171421, Lot Number: 22JBW502; u. VASCULAR CDS, Item Number: CDS981545F, Case UDI/GTIN: 40193489975407, Unit UDI/GTIN: 10193489975406, Lot Number: 22JBU076,22JBU077; v. VALVE CDS, Item Number: CDS981551D, Case UDI/GTIN: 40195327171439, Unit UDI/GTIN: 10195327171438, Lot Number: 22JBR297,22IBS787; w. OPEN HEART PACK-LF, Item Number: CDS981662J, Case UDI/GTIN: 40195327014538, Unit UDI/GTIN: 10195327014537, Lot Number: 22JBV196; x. VASCULAR CDS-LF, Item Number: CDS982412O, Case UDI/GTIN: 40195327212378, Unit UDI/GTIN: 10195327212377, Lot Number: 22IBB001,22IBB003; y. OPEN HEART B CDS-LF, Item Number: CDS982423L, Case UDI/GTIN: 40193489419802, Unit UDI/GTIN: 10193489419801, Lot Number: 22JBQ337; z. CRANIOTOMY CDS, Item Number: CDS982480P, Case UDI/GTIN: 40195327195671, Unit UDI/GTIN: 10195327195670, Lot Number: 22IDB602; aa. OPEN UROLOGY CDS-LF, Item Number: CDS982482I, Case UDI/GTIN: 40195327071777, Unit UDI/GTIN: 10195327071776, Lot Number: 22JDB005,22IDB497; bb. TOTAL KNEE CDS, Item Number: CDS982486M, Case UDI/GTIN: 40195327092345, Unit UDI/GTIN: 10195327092344, Lot Number: 22KDA380; cc. LOWER EXTREMITY CDS-LF, Item Number: CDS982489J, Case UDI/GTIN: 40195327090754, Unit UDI/GTIN: 10195327090753, Lot Number: 22JDB330,22IDB911; dd. LAMINECTOMY CDS, Item Number: CDS982491Q, Case UDI/GTIN: 40195327195725, Unit UDI/GTIN: 10195327195724, Lot Number: 22JDB539,22JDA137; ee. ENDOVASCULAR CDS, Item Number: CDS982659M, Case UDI/GTIN: 40193489204187, Unit UDI/GTIN: 10193489204186, Lot Number: 22KLA219,22JLB019,22ILB085; ff. VASCULAR, Item Number: CDS982699J, Case UDI/GTIN: 40193489418102, Unit UDI/GTIN: 10193489418101, Lot Number: 22KBB744,22KBB751,22KBB749; gg. VASCULAR CDS-3, Item Number: CDS983002D, Case UDI/GTIN: 40889942000433, Unit UDI/GTIN: 10889942000432, Lot Number: 22JLA875,22ILA255; hh. VASCULAR ACCESS CDS, Item Number: CDS983105D, Case UDI/GTIN: 40193489635509, Unit UDI/GTIN: 10193489635508, Lot Number: 22JBC333; ii. ZALE PUMP CDS, Item Number: CDS983187G, Case UDI/GTIN: 40195327258529, Unit UDI/GTIN: 10195327258528, Lot Number: 22JBX916; jj. CUH ENDOVASCULAR CDS, Item Number: CDS983192G, Case UDI/GTIN: 40193489699068, Unit UDI/GTIN: 10193489699067, Lot Number: 22JBF027,22HBY314; kk. CUH MINOR VASCULAR CDS, Item Number: CDS983196G, Case UDI/GTIN: 40195327164660, Unit UDI/GTIN: 10195327164669, Lot Number: 22JBT201,22IBB523; ll. FHT CVOR CABG, Item Number: CDS983346I, Case UDI/GTIN: 40193489929332, Unit UDI/GTIN: 10193489929331, Lot Number: 22IBU546; mm. OPEN HEART CDS, Item Number: CDS983451Q, Case UDI/GTIN: 40195327165186, Unit UDI/GTIN: 10195327165185, Lot Number: 22JBY402; nn. OPEN HEART CDS, Item Number: CDS983513F, Case UDI/GTIN: 40193489843720, Unit UDI/GTIN: 10193489843729, Lot Number: 22IBD426; oo. CAROTID ENDARTERECTOMY CDS-LF, Item Number: CDS983637I, Case UDI/GTIN: 40195327228126, Unit UDI/GTIN: 10195327228125, Lot Number: 22KBC672; pp. PACER CDS, Item Number: CDS983686I, Case UDI/GTIN: 40193489852982, Unit UDI/GTIN: 10193489852981, Lot Number: 22JBL438,22IBU735; qq. PERIPHERAL VASCULAR CDS, Item Number: CDS983723I, Case UDI/GTIN: 40195327228157, Unit UDI/GTIN: 10195327228156, Lot Number: 22JBR360,22IBP608; rr. ACH OPEN HEART, Item Number: CDS983773I, Case UDI/GTIN: 40193489847124, Unit UDI/GTIN: 10193489847123, Lot Number: 22IBJ338; ss. ACH OPEN HEART, Item Number: CDS983773J, Case UDI/GTIN: 40195327233618, Unit UDI/GTIN: 10195327233617, Lot Number: 22JBH775; tt. OPEN HEART CDS, Item Number: CDS984355G, Case UDI/GTIN: 40193489484633, Unit UDI/GTIN: 10193489484632, Lot Number: 22JLB146,22ILB092,22ILA721; uu. VASCULAR CDS, Item Number: CDS985215D, Case UDI/GTIN: 40195327110797, Unit UDI/GTIN: 10195327110796, Lot Number: 22IBR023,22IBA153; vv. CV CDS, Item Number: CDS985395D, Case UDI/GTIN: 40193489859714, Unit UDI/GTIN: 10193489859713, Lot Number: 22JBI301,22IBU577; ww. OPEN HEART CABG PACK-LF, Item Number: DYNJ0149567C, Case UDI/GTIN: 40195327235520, Unit UDI/GTIN: 10195327235529, Lot Number: 22IBD436; xx. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0151111B, Case UDI/GTIN: 40889942050797, Unit UDI/GTIN: 10889942050796, Lot Number: 22IDB491,22IDA147; yy. CARDIOVASCULAR PACK-LF, Item Number: DYNJ0160327B, Case UDI/GTIN: 40889942051770, Unit UDI/GTIN: 10889942051779, Lot Number: 22JDA346; zz. VASCULAR HARPER PACK-LF, Item Number: DYNJ0160636F, Case UDI/GTIN: 40193489205566, Unit UDI/GTIN: 10193489205565, Lot Number: 22IDA733,22HDC250; aaa. CABG 1 OR 2 HARPER PACK, Item Number: DYNJ0160742D, Case UDI/GTIN: 40195327005970, Unit UDI/GTIN: 10195327005979, Lot Number: 22IDB925,22HDA618; bbb. TAVR 1 PACK-LF, Item Number: DYNJ0170415G, Case UDI/GTIN: 40195327167685, Unit UDI/GTIN: 10195327167684, Lot Number: 22HMD027; ccc. ENDO VASCULAR PACK-LF, Item Number: DYNJ0236704N, Case UDI/GTIN: 40193489720670, Unit UDI/GTIN: 10193489720679, Lot Number: 22IME561; ddd. OPEN HEART A & B PACK, Item Number: DYNJ0236832P, Case UDI/GTIN: 40193489404631, Unit UDI/GTIN: 10193489404630, Lot Number: 22HMB796; eee. PACEMAKER IMPLANT PACK-LF, Item Number: DYNJ0373237M, Case UDI/GTIN: 40193489369015, Unit UDI/GTIN: 10193489369014, Lot Number: 22JBO014; fff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ0375688L, Case UDI/GTIN: 40193489724258, Unit UDI/GTIN: 10193489724257, Lot Number: 22JBI091; ggg. PACEMAKER PACK-LF, Item Number: DYNJ0378729F, Case UDI/GTIN: 40888277763310, Unit UDI/GTIN: 10888277763319, Lot Number: 22IMB260; hhh. RR-NEURO VASCULAR PACK-LF, Item Number: DYNJ0394874L, Case UDI/GTIN: 40193489800006, Unit UDI/GTIN: 10193489800005, Lot Number: 22GLB222; iii. CARDIAC CHEST PACK 80701, Item Number: DYNJ04439N, Case UDI/GTIN: 40195327160303, Unit UDI/GTIN: 10195327160302, Lot Number: 22JBI819; jjj. OPEN HEART PACK-LF, Item Number: DYNJ04506V, Case UDI/GTIN: 40193489510318, Unit UDI/GTIN: 10193489510317, Lot Number: 22JMC546; kkk. PACEMAKER PACK-LF, Item Number: DYNJ04516N, Case UDI/GTIN: 40888277744517, Unit UDI/GTIN: 10888277744516, Lot Number: 22JMH689,22IMF834; lll. CARDIOVASCULAR PACK-LF, Item Number: DYNJ04676T, Case UDI/GTIN: 40193489805742, Unit UDI/GTIN: 10193489805741, Lot Number: 22JMD285; mmm. OPEN HEART PACK A & B, Item Number: DYNJ04822R, Case UDI/GTIN: 40195327188178, Unit UDI/GTIN: 10195327188177, Lot Number: 22JBC142; nnn. MINOR VASCULAR PACK, Item Number: DYNJ04852O, Case UDI/GTIN: 40193489303897, Unit UDI/GTIN: 10193489303896, Lot Number: 22IMF450; ooo. OPEN HEART PACK-LF, Item Number: DYNJ0530912AK, Case UDI/GTIN: 40195327167661, Unit UDI/GTIN: 10195327167660, Lot Number: 22IBO170; ppp. SMALL VASCULAR PACK-LF, Item Number: DYNJ0536987AC, Case UDI/GTIN: 40195327170616, Unit UDI/GTIN: 10195327170615, Lot Number: 22JMF083; qqq. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0536993AI, Case UDI/GTIN: 40195327167630, Unit UDI/GTIN: 10195327167639, Lot Number: 22IBG292; rrr. PEDIATRIC CARDIAC PACK-LF, Item Number: DYNJ0537013AA, Case UDI/GTIN: 40195327167678, Unit UDI/GTIN: 10195327167677, Lot Number: 22JMC081; sss. OH VALVE PACK-LF, Item Number: DYNJ0541850O, Case UDI/GTIN: 40195327167654, Unit UDI/GTIN: 10195327167653, Lot Number: 22IBS422; ttt. HEART OVERHEAD TABLE PACK, Item Number: DYNJ0778508I, Case UDI/GTIN: 40195327049462, Unit UDI/GTIN: 10195327049461, Lot Number: 22IME042; uuu. OPEN HEART PACK, Item Number: DYNJ0826299T, Case UDI/GTIN: 40193489377980, Unit UDI/GTIN: 10193489377989, Lot Number: 22IBB762,22HBO328; vvv. PACEMAKER PACK-LF, Item Number: DYNJ0826630L, Case UDI/GTIN: 40195327177073, Unit UDI/GTIN: 10195327177072, Lot Number: 22IMH402,22IMF458; www. VASCULAR PACK-LF, Item Number: DYNJ0901358J, Case UDI/GTIN: 40195327156559, Unit UDI/GTIN: 10195327156558, Lot Number: 22IDA821; xxx. OPEN HEART PACK, Item Number: DYNJ0911264O, Case UDI/GTIN: 40195327124329, Unit UDI/GTIN: 10195327124328, Lot Number: 22IBQ743,22HBY040; yyy. VASCULAR PACK, Item Number: DYNJ14078F, Case UDI/GTIN: 40193489927840, Unit UDI/GTIN: 10193489927849, Lot Number: 22IBI839; zzz. CV BASIC SET UP PACK, Item Number: DYNJ14224F, Case UDI/GTIN: 40193489927680, Unit UDI/GTIN: 10193489927689, Lot Number: 22JBS669; aaaa. UNIVERSAL OPEN HEART PACK, Item Number: DYNJ14225F, Case UDI/GTIN: 40888277944078, Unit UDI/GTIN: 10888277944077, Lot Number: 22HBG261; bbbb. VASCULAR BYPASS PACK-LF, Item Number: DYNJ17470G, Case UDI/GTIN: 40195327224555, Unit UDI/GTIN: 10195327224554, Lot Number: 22JBW106,22JBD564,22IBM206; cccc. BMC CABG PACK A, Item Number: DYNJ17475J, Case UDI/GTIN: 40195327224807, Unit UDI/GTIN: 10195327224806, Lot Number: 22IBN857,22IBA835,22HBO577,22HBP255; dddd. CUSTOM CAROTID, Item Number: DYNJ20266K, Case UDI/GTIN: 40195327052943, Unit UDI/GTIN: 10195327052942, Lot Number: 22IBJ739; eeee. A-V FISTULA PACK-LF, Item Number: DYNJ20502P, Case UDI/GTIN: 40195327024414, Unit UDI/GTIN: 10195327024413, Lot Number: 22JDB304,22IDC077,22IDA958,22IDA175; ffff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ20503P, Case UDI/GTIN: 40195327024605, Unit UDI/GTIN: 10195327024604, Lot Number: 22IDA018; gggg. ECMO PACK, Item Number: DYNJ21245N, Case UDI/GTIN: 40193489935708, Unit UDI/GTIN: 10193489935707, Lot Number: 22JBM468,22HBQ114; hhhh. HEART PACK, Item Number: DYNJ21246P, Case UDI/GTIN: 40193489935715, Unit UDI/GTIN: 10193489935714, Lot Number: 22HBK069; iiii. CABG PACK A&B, Item Number: DYNJ21971AD, Case UDI/GTIN: 40195327227051, Unit UDI/GTIN: 10195327227050, Lot Number: 22JDA281,22IDA306; jjjj. OPEN HEART PACK, Item Number: DYNJ22035K, Case UDI/GTIN: 40889942029052, Unit UDI/GTIN: 10889942029051, Lot Number: 22IBQ625,22IBE372,22HBT001; kkkk. CV A & B, Item Number: DYNJ22215M, Case UDI/GTIN: 40195327058068, Unit UDI/GTIN: 10195327058067, Lot Number: 22HDB323; llll. PEDIATRIC OPEN HEART-NS-LF, Item Number: DYNJ22230Q, Case UDI/GTIN: 40193489962728, Unit UDI/GTIN: 10193489962727, Lot Number: 22IBQ407,22HBP292,22HBP293,22HBP295; mmmm. PACEMAKER NORTH, Item Number: DYNJ22388F, Case UDI/GTIN: 40889942598510, Unit UDI/GTIN: 10889942598519, Lot Number: 22HBX429; nnnn. OPEN HEART PACK, Item Number: DYNJ22851D, Case UDI/GTIN: 40884389685229, Unit UDI/GTIN: 10884389685228, Lot Number: 22HBP275; oooo. SVMMC CORE OPEN HEART PACK-LF, Item Number: DYNJ22971T, Case UDI/GTIN: 40195327136834, Unit UDI/GTIN: 10195327136833, Lot Number: 22IBO902; pppp. PACEMAKER TRAY-LF, Item Number: DYNJ23050C, Case UDI/GTIN: 40193489948449, Unit UDI/GTIN: 10193489948448, Lot Number: 22JMG953,22IMI497,22IMB289; qqqq. PACEMAKER PACK, Item Number: DYNJ24836M, Case UDI/GTIN: 40889942532477, Unit UDI/GTIN: 10889942532476, Lot Number: 22JBK563; rrrr. MAJOR VASCULAR-RF-LF, Item Number: DYNJ24932P, Case UDI/GTIN: 40195327160150, Unit UDI/GTIN: 10195327160159, Lot Number: 22IBT463; ssss. AV FISTULA-LF, Item Number: DYNJ24944K, Case UDI/GTIN: 40195327045310, Unit UDI/GTIN: 10195327045319, Lot Number: 22IBO282; tttt. PACEMAKER PACK, Item Number: DYNJ25865F, Case UDI/GTIN: 40193489387095, Unit UDI/GTIN: 10193489387094, Lot Number: 22JBJ504,22JBK347,22IBU602; uuuu. VASCULAR PACK, Item Number: DYNJ27559O, Case UDI/GTIN: 40195327155507, Unit UDI/GTIN: 10195327155506, Lot Number: 22JBS418; vvvv. PACEMAKER, Item Number: DYNJ27798D, Case UDI/GTIN: 40889942000532, Unit UDI/GTIN: 10889942000531, Lot Number: 22JBI655; wwww. MAJOR VASCULAR PACK, Item Number: DYNJ31398M, Case UDI/GTIN: 40193489735001, Unit UDI/GTIN: 10193489735000, Lot Number: 22ILA207; xxxx. MAJOR VASCULAR PACK, Item Number: DYNJ31398N, Case UDI/GTIN: 40195327259281, Unit UDI/GTIN: 10195327259280, Lot Number: 22JLA632,22JLA374; yyyy. VASCULAR PACK, Item Number: DYNJ31902L, Case UDI/GTIN: 40193489776073, Unit UDI/GTIN: 10193489776072, Lot Number: 22IBU515,22HBR178; zzzz. PACEMAKER PACK-LF, Item Number: DYNJ33062B, Case UDI/GTIN: 40884389604732, Unit UDI/GTIN: 10884389604731, Lot Number: 22HBY351; aaaaa. RRMC CABG AUXILIARY TRAY, Item Number: DYNJ33387I, Case UDI/GTIN: 40193489915557, Unit UDI/GTIN: 10193489915556, Lot Number: 22JBF985; bbbbb. RRMC OPEN HEART PACK, Item Number: DYNJ33394M, Case UDI/GTIN: 40193489918640, Unit UDI/GTIN: 10193489918649, Lot Number: 22JBT973,22HBF896; ccccc. MAJOR VASCULAR PACK, Item Number: DYNJ34102D, Case UDI/GTIN: 40193489551953, Unit UDI/GTIN: 10193489551952, Lot Number: 22IME737; ddddd. PACEMAKER PACK, Item Number: DYNJ35201I, Case UDI/GTIN: 40195327134113, Unit UDI/GTIN: 10195327134112, Lot Number: 22JBO409; eeeee. PACEMAKER TRAY, Item Number: DYNJ35519F, Case UDI/GTIN: 40193489809221, Unit UDI/GTIN: 10193489809220, Lot Number: 22JMG600; fffff. PACEMAKER PACK, Item Number: DYNJ36025C, Case UDI/GTIN: 40193489700269, Unit UDI/GTIN: 10193489700268, Lot Number: 22JMI234; ggggg. PACEMAKER PACK, Item Number: DYNJ36312K, Case UDI/GTIN: 40195327156436, Unit UDI/GTIN: 10195327156435, Lot Number: 22JMA898; hhhhh. AV FISTULA PK-LF, Item Number: DYNJ36735D, Case UDI/GTIN: 40195327147229, Unit UDI/GTIN: 10195327147228, Lot Number: 22IBJ526; iiiii. FHT PACER PACK, Item Number: DYNJ37114G, Case UDI/GTIN: 40193489932080, Unit UDI/GTIN: 10193489932089, Lot Number: 22JBO139,22IBS426; jjjjj. PACEMAKER SET UP PACK, Item Number: DYNJ38232, Case UDI/GTIN: 40884389685762, Unit UDI/GTIN: 10884389685761, Lot Number: 22JBV577; kkkkk. MAJOR VASCULAR PACK, Item Number: DYNJ38318F, Case UDI/GTIN: 40193489728515, Unit UDI/GTIN: 10193489728514, Lot Number: 22IME581,22IME054; lllll. PACEMAKER PACK-LF, Item Number: DYNJ38702, Case UDI/GTIN: 40884389709062, Unit UDI/GTIN: 10884389709061, Lot Number: 22HDB882; mmmmm. CAROTID PACK, Item Number: DYNJ39488I, Case UDI/GTIN: 40195327249510, Unit UDI/GTIN: 10195327249519, Lot Number: 22IMD856; nnnnn. MAJOR VASCULAR PACK, Item Number: DYNJ39542F, Case UDI/GTIN: 40193489987646, Unit UDI/GTIN: 10193489987645, Lot Number: 22JMB308,22IMC327; ooooo. VASCULAR PACK GH-LF, Item Number: DYNJ39840C, Case UDI/GTIN: 40195327177080, Unit UDI/GTIN: 10195327177089, Lot Number: 22IMD146,22IMD147; ppppp. A-V FISTULA PACK GH-LF, Item Number: DYNJ39861C, Case UDI/GTIN: 40195327176830, Unit UDI/GTIN: 10195327176839, Lot Number: 22JME917; qqqqq. VASCULAR PACK MH-LF, Item Number: DYNJ39866C, Case UDI/GTIN: 40195327176342, Unit UDI/GTIN: 10195327176341, Lot Number: 22IMH447,22HMH464; rrrrr. PACEMAKER PACK L J, Item Number: DYNJ40024B, Case UDI/GTIN: 40195327176496, Unit UDI/GTIN: 10195327176495, Lot Number: 22JME764,22IMG357,22HMD989,22GMA585; sssss. OPEN HEART, Item Number: DYNJ40976A, Case UDI/GTIN: 40889942431213, Unit UDI/GTIN: 10889942431212, Lot Number: 22JLA725; ttttt. OPEN HEART SUPPLY TRAY, Item Number: DYNJ41007A, Case UDI/GTIN: 40193489305211, Unit UDI/GTIN: 10193489305210, Lot Number: 22IBN535,22IBE489; uuuuu. PACEMAKER PACK, Item Number: DYNJ41094, Case UDI/GTIN: 40884389896168, Unit UDI/GTIN: 10884389896167, Lot Number: 22JBJ333; vvvvv. PACEMAKER PACK, Item Number: DYNJ41189, Case UDI/GTIN: 40884389898254, Unit UDI/GTIN: 10884389898253, Lot Number: 22JBO177; wwwww. VASCULAR PACK, Item Number: DYNJ41397C, Case UDI/GTIN: 40888277950871, Unit UDI/GTIN: 10888277950870, Lot Number: 22HBY320; xxxxx. BASIC OPEN HEART PACK A B, Item Number: DYNJ41485, Case UDI/GTIN: 40884389909585, Unit UDI/GTIN: 10884389909584, Lot Number: 22JBQ405,22IBK720,22IBA814; yyyyy. VASCULAR PACK, Item Number: DYNJ41519A, Case UDI/GTIN: 40888277935243, Unit UDI/GTIN: 10888277935242, Lot Number: 22IBR239,22HBT658; zzzzz. OPEN HEART TRAY A-LF, Item Number: DYNJ42156, Case UDI/GTIN: 40884389913957, Unit UDI/GTIN: 10884389913956, Lot Number: 22JBC984,22IBQ308,22IBH233; aaaaaa. VASCULAR PACK, Item Number: DYNJ42554B, Case UDI/GTIN: 40889942158332, Unit UDI/GTIN: 10889942158331, Lot Number: 22IBO207; bbbbbb. PACEMAKER PACK, Item Number: DYNJ42557B, Case UDI/GTIN: 40889942135807, Unit UDI/GTIN: 10889942135806, Lot Number: 22JBJ624,22HBZ316; cccccc. OPEN HEART PACK, Item Number: DYNJ42580C, Case UDI/GTIN: 40889942816386, Unit UDI/GTIN: 10889942816385, Lot Number: 22HBV705; dddddd. ENDOVASCULAR PACK-LF, Item Number: DYNJ42831F, Case UDI/GTIN: 40193489880329, Unit UDI/GTIN: 10193489880328, Lot Number: 22JBA341,22IBG065; eeeeee. VASCULAR PACK-LF, Item Number: DYNJ42849C, Case UDI/GTIN: 40889942849544, Unit UDI/GTIN: 10889942849543, Lot Number: 22IBG029; ffffff. BASIC OPEN HEART PACK-LF, Item Number: DYNJ43399I, Case UDI/GTIN: 40195327209385, Unit UDI/GTIN: 10195327209384, Lot Number: 22JBI149; gggggg. OPEN VASCULAR PACK-LF, Item Number: DYNJ43414D, Case UDI/GTIN: 40195327136681, Unit UDI/GTIN: 10195327136680, Lot Number: 22JMB316; hhhhhh. PK, EP LAB PACEMAKER, Item Number: DYNJ43663A, Case UDI/GTIN: 40193489793681, Unit UDI/GTIN: 10193489793680, Lot Number: 22JBO225; iiiiii. PK, OPEN HEART-CABG, Item Number: DYNJ43666C, Case UDI/GTIN: 40193489793674, Unit UDI/GTIN: 10193489793673, Lot Number: 22JBT937; jjjjjj. OPEN HEART PACK, Item Number: DYNJ43741B, Case UDI/GTIN: 40889942821076, Unit UDI/GTIN: 10889942821075, Lot Number: 22HBO045; kkkkkk. PK, OPEN HEART- A&B, Item Number: DYNJ43751F, Case UDI/GTIN: 40193489414517, Unit UDI/GTIN: 10193489414516, Lot Number: 22IBO181; llllll. SVMMC VASCULAR MAJOR PACK, Item Number: DYNJ43777J, Case UDI/GTIN: 40193489990189, Unit UDI/GTIN: 10193489990188, Lot Number: 22JBJ507,22IBV692,22IBE494; mmmmmm. CV PACK, Item Number: DYNJ43824, Case UDI/GTIN: 40888277071729, Unit UDI/GTIN: 10888277071728, Lot Number: 22JMC590,22IMD149,22HMD629; nnnnnn. OPEN HEART PACK A AND B, Item Number: DYNJ43858B, Case UDI/GTIN: 40195327200191, Unit UDI/GTIN: 10195327200190, Lot Number: 22IBH029,22HBI610; oooooo. SVMMC CAROTID PACK, Item Number: DYNJ43861F, Case UDI/GTIN: 40193489981644, Unit UDI/GTIN: 10193489981643, Lot Number: 22JBL517; pppppp. PK, OPEN HEART-CABG A&B, Item Number: DYNJ43872A, Case UDI/GTIN: 40889942238942, Unit UDI/GTIN: 10889942238941, Lot Number: 22JBM586; qqqqqq. PK, OPEN HEART-A&B, Item Number: DYNJ43895G, Case UDI/GTIN: 40193489203395, Unit UDI/GTIN: 10193489203394, Lot Number: 22JBM587,22JBJ484,22HBP784; rrrrrr. VASCULAR PACK, Item Number: DYNJ43945I, Case UDI/GTIN: 40193489704243, Unit UDI/GTIN: 10193489704242, Lot Number: 22JMG347,22HMD283; ssssss. PK, OPEN HEART, Item Number: DYNJ43970, Case UDI/GTIN: 40888277077165, Unit UDI/GTIN: 10888277077164, Lot Number: 22JBB067,22IBA908,22HBI904; tttttt. PK, OPEN HEART, Item Number: DYNJ43979A, Case UDI/GTIN: 40889942010784, Unit UDI/GTIN: 10889942010783, Lot Number: 22IBV693; uuuuuu. OPEN HEART PACK, Item Number: DYNJ44025A, Case UDI/GTIN: 40193489204668, Unit UDI/GTIN: 10193489204667, Lot Number: 22IBS470; vvvvvv. PK, OPEN HEART-A&B, Item Number: DYNJ44026C, Case UDI/GTIN: 40193489433518, Unit UDI/GTIN: 10193489433517, Lot Number: 22IBN326,22IBN327; wwwwww. OPEN HEART PACK, Item Number: DYNJ44033, Case UDI/GTIN: 40888277079862, Unit UDI/GTIN: 10888277079861, Lot Number: 22JBI150,22HBY546; xxxxxx. PK, OPEN HEART-CABG, Item Number: DYNJ44067A, Case UDI/GTIN: 40193489757898, Unit UDI/GTIN: 10193489757897, Lot Number: 22JBU916; yyyyyy. PK, OPEN HEART, Item Number: DYNJ44090D, Case UDI/GTIN: 40195327133338, Unit UDI/GTIN: 10195327133337, Lot Number: 22IBN978; zzzzzz. CASTRO CABG-COMPONENT PACK, Item Number: DYNJ44857T, Case UDI/GTIN: 40195327221950, Unit UDI/GTIN: 10195327221959, Lot Number: 22JBD481; aaaaaaa. RE-ENTRY PACK, Item Number: DYNJ44890F, Case UDI/GTIN: 40195327127757, Unit UDI/GTIN: 10195327127756, Lot Number: 22JDA683; bbbbbbb. HEART PACK, Item Number: DYNJ45022B, Case UDI/GTIN: 40193489657938, Unit UDI/GTIN: 10193489657937, Lot Number: 22JBT974,22HBY537,22HBV710; ccccccc. OPEN HEART SUPPLY PACK, Item Number: DYNJ45025A, Case UDI/GTIN: 40889942609131, Unit UDI/GTIN: 10889942609130, Lot Number: 22JLA524,22ILA816; ddddddd. PK, OPEN HEART-CABG, Item Number: DYNJ45048C, Case UDI/GTIN: 40193489808880, Unit UDI/GTIN: 10193489808889, Lot Number: 22IMD722; eeeeeee. CABG PROCEDURE PACK, Item Number: DYNJ45060D, Case UDI/GTIN: 40889942613633, Unit UDI/GTIN: 10889942613632, Lot Number: 22JBM611; fffffff. CABG PACK, Item Number: DYNJ45073I, Case UDI/GTIN: 40195327044726, Unit UDI/GTIN: 10195327044725, Lot Number: 22IBO185; ggggggg. PK, OPEN HEART, Item Number: DYNJ45074C, Case UDI/GTIN: 40193489222679, Unit UDI/GTIN: 10193489222678, Lot Number: 22IBC441,22HBW259; hhhhhhh. VASCULAR GRAFT PACK, Item Number: DYNJ45076C, Case UDI/GTIN: 40889942947424, Unit UDI/GTIN: 10889942947423, Lot Number: 22HBI833; iiiiiii. PK, OPEN HEART, Item Number: DYNJ45179C, Case UDI/GTIN: 40193489204217, Unit UDI/GTIN: 10193489204216, Lot Number: 22IBL978,22HBI927; jjjjjjj. VASCULAR PACK, Item Number: DYNJ45422C, Case UDI/GTIN: 40195327040650, Unit UDI/GTIN: 10195327040659, Lot Number: 22JMF415; kkkkkkk. PK, OPEN HEART, Item Number: DYNJ46237D, Case UDI/GTIN: 40193489322843, Unit UDI/GTIN: 10193489322842, Lot Number: 22JBW004,22IBJ774,22HBR324; lllllll. OPEN HEART MINOR PACK, Item Number: DYNJ46425G, Case UDI/GTIN: 40193489833578, Unit UDI/GTIN: 10193489833577, Lot Number: 22JBW515,22IBT435,22IBH125,22IBH126,22IBH130; mmmmmmm. CABG PACK(CBSJE)227-LF, Item Number: DYNJ47486A, Case UDI/GTIN: 40889942106234, Unit UDI/GTIN: 10889942106233, Lot Number: 22IBQ923; nnnnnnn. OPEN HEART PACK (OHSJC)227, Item Number: DYNJ47493D, Case UDI/GTIN: 40889942324744, Unit UDI/GTIN: 10889942324743, Lot Number: 22IMF207,22IMF212; ooooooo. PACEMAKER PACK, Item Number: DYNJ47619B, Case UDI/GTIN: 40193489730976, Unit UDI/GTIN: 10193489730975, Lot Number: 22JBJ759; ppppppp. BR VASCULAR PACK, Item Number: DYNJ47628A, Case UDI/GTIN: 40888277843340, Unit UDI/GTIN: 10888277843349, Lot Number: 22JBG043; qqqqqqq. VBMC OPEN HEART PACK, Item Number: DYNJ47638A, Case UDI/GTIN: 40193489735377, Unit UDI/GTIN: 10193489735376, Lot Number: 22JBT976,22HBX785; rrrrrrr. PACEMAKER-LF, Item Number: DYNJ47644D, Case UDI/GTIN: 40193489952125, Unit UDI/GTIN: 10193489952124, Lot Number: 22IMH194; sssssss. OPEN HEART PACK-RFD-LF, Item Number: DYNJ47770O, Case UDI/GTIN: 40193489308304, Unit UDI/GTIN: 10193489308303, Lot Number: 22JBB013,22IBI370; ttttttt. PACEMAKER PACK, Item Number: DYNJ47772G, Case UDI/GTIN: 40193489463263, Unit UDI/GTIN: 10193489463262, Lot Number: 22HMD743; uuuuuuu. VASCULAR PACK-LF, Item Number: DYNJ48196C, Case UDI/GTIN: 40193489712460, Unit UDI/GTIN: 10193489712469, Lot Number: 22HBP970; vvvvvvv. CV VASCULAR PACK, Item Number: DYNJ48253J, Case UDI/GTIN: 40193489805735, Unit UDI/GTIN: 10193489805734, Lot Number: 22JMH939; wwwwwww. HEART A&B PACK, Item Number: DYNJ48313F, Case UDI/GTIN: 40193489840354, Unit UDI/GTIN: 10193489840353, Lot Number: 22JBI418,22HBW107; xxxxxxx. OPEN HEART PACK, Item Number: DYNJ49059, Case UDI/GTIN: 40888277815576, Unit UDI/GTIN: 10888277815575, Lot Number: 22HBJ896; yyyyyyy. HAVASU BASIC OPEN HEART PACK, Item Number: DYNJ49104C, Case UDI/GTIN: 40193489776554, Unit UDI/GTIN: 10193489776553, Lot Number: 22IMC796,22HMB847; zzzzzzz. VASCULAR PACK, Item Number: DYNJ49156, Case UDI/GTIN: 40888277819277, Unit UDI/GTIN: 10888277819276, Lot Number: 22HME394; aaaaaaaa. PK, EP LAB, Item Number: DYNJ49513C, Case UDI/GTIN: 40193489268301, Unit UDI/GTIN: 10193489268300, Lot Number: 22JMD840,22IME354,22IME355; bbbbbbbb. PACEMAKER PACK, Item Number: DYNJ49534A, Case UDI/GTIN: 40889942275688, Unit UDI/GTIN: 10889942275687, Lot Number: 22JBU805,22IBG083; cccccccc. CARDIOVASCULAR PACK LJ-LF, Item Number: DYNJ49635F, Case UDI/GTIN: 40195327191406, Unit UDI/GTIN: 10195327191405, Lot Number: 22IMI321,22IMH472,22IMD161; dddddddd. PACEMAKER PACK, Item Number: DYNJ50379A, Case UDI/GTIN: 40889942300922, Unit UDI/GTIN: 10889942300921, Lot Number: 22JBX697; eeeeeeee. CAROTID VASCULAR ENDARTERECTMY, Item Number: DYNJ50528M, Case UDI/GTIN: 40195327129690, Unit UDI/GTIN: 10195327129699, Lot Number: 22HBX666; ffffffff. MARQUETTE CV PACK, Item Number: DYNJ50987C, Case UDI/GTIN: 40193489499088, Unit UDI/GTIN: 10193489499087, Lot Number: 22HDB888; gggggggg. DR DANIELSON AC PACK, Item Number: DYNJ51038Q, Case UDI/GTIN: 40195327174072, Unit UDI/GTIN: 10195327174071, Lot Number: 22JBI155; hhhhhhhh. PACEMAKER INSERTION PACK, Item Number: DYNJ51097A, Case UDI/GTIN: 40193489985390, Unit UDI/GTIN: 10193489985399, Lot Number: 22HDC254; iiiiiiii. MAJOR VASCULAR PACK, Item Number: DYNJ51305B, Case UDI/GTIN: 40193489460972, Unit UDI/GTIN: 10193489460971, Lot Number: 22JMG823; jjjjjjjj. PACEMAKER PACK-LF, Item Number: DYNJ51844B, Case UDI/GTIN: 40889942615774, Unit UDI/GTIN: 10889942615773, Lot Number: 22JMA106; kkkkkkkk. MAJOR VASCULAR PACK-LF, Item Number: DYNJ52054A, Case UDI/GTIN: 40195327104567, Unit UDI/GTIN: 10195327104566, Lot Number: 22HBL905; llllllll. HEART PACK, Item Number: DYNJ52362G, Case UDI/GTIN: 40195327237739, Unit UDI/GTIN: 10195327237738, Lot Number: 22IBK723; mmmmmmmm. VALVE PACK, Item Number: DYNJ52363D, Case UDI/GTIN: 40195327183807, Unit UDI/GTIN: 10195327183806, Lot Number: 22JBD487,22IBS584; nnnnnnnn. PACEMAKER PACK, Item Number: DYNJ53636A, Case UDI/GTIN: 40193489292863, Unit UDI/GTIN: 10193489292862, Lot Number: 22IBQ560; oooooooo. CABG PACK, Item Number: DYNJ53827, Case UDI/GTIN: 40889942444015, Unit UDI/GTIN: 10889942444014, Lot Number: 22JBD306; pppppppp. VASCULAR PACK, Item Number: DYNJ53995G, Case UDI/GTIN: 40195327073764, Unit UDI/GTIN: 10195327073763, Lot Number: 22IBD708; qqqqqqqq. VASCULAR PACK-LF, Item Number: DYNJ54381G, Case UDI/GTIN: 40193489815444, Unit UDI/GTIN: 10193489815443, Lot Number: 22JMH270; rrrrrrrr. CABG INTRA OP SURGICOUNT PACK, Item Number: DYNJ55823G, Case UDI/GTIN: 40193489953498, Unit UDI/GTIN: 10193489953497, Lot Number: 22JBC268,22HBX703; ssssssss. PK, OPEN HEART, Item Number: DYNJ56089, Case UDI/GTIN: 40889942603344, Unit UDI/GTIN: 10889942603343, Lot Number: 22IBM871,22HBW951,22HMC219; tttttttt. PEDIATRIC OPEN HEART PACK, Item Number: DYNJ56796, Case UDI/GTIN: 40889942681458, Unit UDI/GTIN: 10889942681457, Lot Number: 22JMG835,22IMB362,22HMC357; uuuuuuuu. PCNL PACK-LF, Item Number: DYNJ56954B, Case UDI/GTIN: 40889942778158, Unit UDI/GTIN: 10889942778157, Lot Number: 22IMG593; vvvvvvvv. CAROTID PACK-LF, Item Number: DYNJ57646B, Case UDI/GTIN: 40193489828505, Unit UDI/GTIN: 10193489828504, Lot Number: 22IME979; wwwwwwww. ENSEMBLE VALVE-LF, Item Number: DYNJ58123B, Case UDI/GTIN: 40195327078721, Unit UDI/GTIN: 10195327078720, Lot Number: 22IBL147,22IBK251,22HBF572; xxxxxxxx. PONTAGE-LF, Item Number: DYNJ58124C, Case UDI/GTIN: 40195327078738, Unit UDI/GTIN: 10195327078737, Lot Number: 22HBH900; yyyyyyyy. MINOR CARDIAC PACK-LF, Item Number: DYNJ58381C, Case UDI/GTIN: 40193489230711, Unit UDI/GTIN: 10193489230710, Lot Number: 22JMC834,22JMC835,22HMC125; zzzzzzzz. FEMORAL A LINE PACK-LF, Item Number: DYNJ59102A, Case UDI/GTIN: 40195327040643, Unit UDI/GTIN: 10195327040642, Lot Number: 22IMD766; aaaaaaaaa. PACEMAKER PACK, Item Number: DYNJ59123, Case UDI/GTIN: 40889942937500, Unit UDI/GTIN: 10889942937509, Lot Number: 22HLB249; bbbbbbbbb. VASCULAR PACK, Item Number: DYNJ59361B, Case UDI/GTIN: 40195327000340, Unit UDI/GTIN: 10195327000349, Lot Number: 22JBI630,22IBM237; ccccccccc. OPEN HEART A&B PACK, Item Number: DYNJ59604A, Case UDI/GTIN: 40193489457927, Unit UDI/GTIN: 10193489457926, Lot Number: 22JBT640,22IBK862,22HBZ301; ddddddddd. PK, OPEN HEART, Item Number: DYNJ59695B, Case UDI/GTIN: 40193489791182, Unit UDI/GTIN: 10193489791181, Lot Number: 22JBU415,22IBJ783; eeeeeeeee. PACEMAKER PACK, Item Number: DYNJ60055, Case UDI/GTIN: 40888277794147, Unit UDI/GTIN: 10888277794146, Lot Number: 22JBK003,22HBY483; fffffffff. PK, OPEN HEART-FIRSTY/HANNA, Item Number: DYNJ63108A, Case UDI/GTIN: 40193489781381, Unit UDI/GTIN: 10193489781380, Lot Number: 22JMD080,22IMB793; ggggggggg. CABG ACCESSORIES, Item Number: DYNJ63134A, Case UDI/GTIN: 40193489432597, Unit UDI/GTIN: 10193489432596, Lot Number: 22IBC805; hhhhhhhhh. PEDS HEART MAJOR, Item Number: DYNJ63135, Case UDI/GTIN: 40193489721615, Unit UDI/GTIN: 10193489721614, Lot Number: 22IBD750; iiiiiiiii. HEART MAJOR, Item Number: DYNJ63136B, Case UDI/GTIN: 40193489833585, Unit UDI/GTIN: 10193489833584, Lot Number: 22JBX699,22IBT444; jjjjjjjjj. VASCULAR PACK, Item Number: DYNJ63182, Case UDI/GTIN: 40193489723404, Unit UDI/GTIN: 10193489723403, Lot Number: 22JBI165,22HBL764; kkkkkkkkk. NOLEN VALVE PACK, Item Number: DYNJ63767B, Case UDI/GTIN: 40193489266796, Unit UDI/GTIN: 10193489266795, Lot Number: 22JBI672; lllllllll. CV MINOR PK, Item Number: DYNJ64038, Case UDI/GTIN: 40193489782142, Unit UDI/GTIN: 10193489782141, Lot Number: 22IMI061,22HMD756; mmmmmmmmm. HEART CABG PK, Item Number: DYNJ64040C, Case UDI/GTIN: 40195327050215, Unit UDI/GTIN: 10195327050214, Lot Number: 22IMF685; nnnnnnnnn. NON CABG PK, Item Number: DYNJ64046B, Case UDI/GTIN: 40195327050208, Unit UDI/GTIN: 10195327050207, Lot Number: 22IMF875; ooooooooo. CVOR ENDOVASCULAR PACK, Item Number: DYNJ64506A, Case UDI/GTIN: 40193489971065, Unit UDI/GTIN: 10193489971064, Lot Number: 22JBN274,22IBS808; ppppppppp. VASCULAR, Item Number: DYNJ64767A, Case UDI/GTIN: 40193489456159, Unit UDI/GTIN: 10193489456158, Lot Number: 22IDA696; qqqqqqqqq. VASCULAR SHARED, Item Number: DYNJ64801B, Case UDI/GTIN: 40195327218127, Unit UDI/GTIN: 10195327218126, Lot Number: 22JDB419,22HDC153; rrrrrrrrr. CARDIAC PACK, Item Number: DYNJ65027B, Case UDI/GTIN: 40193489471992, Unit UDI/GTIN: 10193489471991, Lot Number: 22JBT419,22JBE649; sssssssss. PACEMAKER PACK, Item Number: DYNJ66006, Case UDI/GTIN: 40193489312585, Unit UDI/GTIN: 10193489312584, Lot Number: 22HBP090; ttttttttt. OPEN HEART ORANGE PARK PACK, Item Number: DYNJ66157, Case UDI/GTIN: 40193489319744, Unit UDI/GTIN: 10193489319743, Lot Number: 22JBO191; uuuuuuuuu. VASCULAR PACK, Item Number: DYNJ66577, Case UDI/GTIN: 40193489360968, Unit UDI/GTIN: 10193489360967, Lot Number: 22IBM137; vvvvvvvvv. VASCULAR PACK, Item Number: DYNJ66614, Case UDI/GTIN: 40193489366410, Unit UDI/GTIN: 10193489366419, Lot Number: 22IMF244; wwwwwwwww. VASCULAR PACK, Item Number: DYNJ67151A, Case UDI/GTIN: 40195327023813, Unit UDI/GTIN: 10195327023812, Lot Number: 22JBX719,22IBJ917,22HBX262,22

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 9 of 38

Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTULA-LF u. AV FISTULA v. PORT VENOUS ACCESS w. AV FISTULA

Z-1068-2023
Recall number
Z-1068-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
622 cases (1,619 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. PORT/TRACH INSERTION CDS-3, Item Number: CDS983004D, Case UDI/GTIN: 40889942000464, Unit UDI/GTIN: 10889942000463, Lot Number: 22IBF922,22IBE764; b. RESIDENT DERM SURG PACK, Item Number: DYNDA2997, Case UDI/GTIN: 40195327235353, Unit UDI/GTIN: 10195327235352, Lot Number: 22JBR611; c. THROMBECTOMY PACK-LF, Item Number: DYNJ0160348B, Case UDI/GTIN: 40889942211594, Unit UDI/GTIN: 10889942211593, Lot Number: 22IDB621; d. AV FISTULA PACK, Item Number: DYNJ01966N, Case UDI/GTIN: 40193489383769, Unit UDI/GTIN: 10193489383768, Lot Number: 22IMA429; e. AV SHUNT PACK-LF, Item Number: DYNJ0781844W, Case UDI/GTIN: 40193489226530, Unit UDI/GTIN: 10193489226539, Lot Number: 22IMG652; f. RR-VP SHUNT PACK-LF, Item Number: DYNJ0785917M, Case UDI/GTIN: 40193489412827, Unit UDI/GTIN: 10193489412826, Lot Number: 22GMH382; g. VEIN HARVESTING PACK-LF, Item Number: DYNJ0826732I, Case UDI/GTIN: 40193489377973, Unit UDI/GTIN: 10193489377972, Lot Number: 22IMF839; h. AV FISTULA PACK-LF, Item Number: DYNJ0826753O, Case UDI/GTIN: 40193489384292, Unit UDI/GTIN: 10193489384291, Lot Number: 22JMH548,22IMC908; i. PK, GEN-BARIATRIC, Item Number: DYNJ33890B, Case UDI/GTIN: 40193489213455, Unit UDI/GTIN: 10193489213454, Lot Number: 22JBV659,22HBW898; j. VEIN PACK, Item Number: DYNJ36309F, Case UDI/GTIN: 40195327078035, Unit UDI/GTIN: 10195327078034, Lot Number: 22IMC227; k. VENOUS ACCESS PACK-LF, Item Number: DYNJ36725D, Case UDI/GTIN: 40195327148714, Unit UDI/GTIN: 10195327148713, Lot Number: 22HBO043; l. VENOUS ACCESS PACK, Item Number: DYNJ42694A, Case UDI/GTIN: 40193489983341, Unit UDI/GTIN: 10193489983340, Lot Number: 22JBK167,22IBJ914; m. VASCULAR ACCESS PACK, Item Number: DYNJ45071C, Case UDI/GTIN: 40889942943303, Unit UDI/GTIN: 10889942943302, Lot Number: 22IBO914; n. ARTERIOGRAM PACK, Item Number: DYNJ53095A, Case UDI/GTIN: 40195327148721, Unit UDI/GTIN: 10195327148720, Lot Number: 22IBM491,22HBY446; o. AV FISTULA/GRAFT INSER PK, Item Number: DYNJ57152, Case UDI/GTIN: 40889942721888, Unit UDI/GTIN: 10889942721887, Lot Number: 22IBT472; p. VEIN ABLATION PACK, Item Number: DYNJ62889B, Case UDI/GTIN: 40195327030958, Unit UDI/GTIN: 10195327030957, Lot Number: 22JDB544; q. PORT PACK, Item Number: DYNJ64675, Case UDI/GTIN: 40193489212144, Unit UDI/GTIN: 10193489212143, Lot Number: 22IBP112; r. MINOR VASCULAR, Item Number: DYNJ66148A, Case UDI/GTIN: 40195327096329, Unit UDI/GTIN: 10195327096328, Lot Number: 22JBL900,22HBP630,22HBG264; s. FISTULA PACK, Item Number: DYNJ66502, Case UDI/GTIN: 40193489358507, Unit UDI/GTIN: 10193489358506, Lot Number: 22HBO053; t. AV FISTULA-LF, Item Number: DYNJ901747K, Case UDI/GTIN: 40193489482165, Unit UDI/GTIN: 10193489482164, Lot Number: 22JDC010,22JDA876; u. AV FISTULA, Item Number: DYNJ903417F, Case UDI/GTIN: 40193489418218, Unit UDI/GTIN: 10193489418217, Lot Number: 22KBF261,22KBG353; v. PORT VENOUS ACCESS, Item Number: DYNJ903426F, Case UDI/GTIN: 40193489418447, Unit UDI/GTIN: 10193489418446, Lot Number: 22JBR462,22JBB174,22HBS253; w. AV FISTULA, Item Number: DYNJ903726B, Case UDI/GTIN: 40193489966849, Unit UDI/GTIN: 10193489966848, Lot Number: 22KBD044,22IBO370,22HBX959;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 10 of 38

Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST

Z-1069-2023
Recall number
Z-1069-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
200 cases (858 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. BREAST BIOPSY PACK-LF, Item Number: DYNJ0160598B, Case UDI/GTIN: 40889942051930, Unit UDI/GTIN: 10889942051939, Lot Number: 22IDB852; b. BREAST BIOPSY PACK, Item Number: DYNJ45087C, Case UDI/GTIN: 40195327044764, Unit UDI/GTIN: 10195327044763, Lot Number: 22JBO180; c. LAPAROTOMY PACK, Item Number: DYNJ55654B, Case UDI/GTIN: 40193489956727, Unit UDI/GTIN: 10193489956726, Lot Number: 22JDA974; d. BREAST PACK, Item Number: DYNJ56546C, Case UDI/GTIN: 40195327231164, Unit UDI/GTIN: 10195327231163, Lot Number: 22JBE655; e. SOFT TISSUE PACK, Item Number: DYNJ68311, Case UDI/GTIN: 40193489821933, Unit UDI/GTIN: 10193489821932, Lot Number: 22JBL797,22GBV060; f. HEMORRHOID PACK, Item Number: DYNJ69404, Case UDI/GTIN: 40193489936620, Unit UDI/GTIN: 10193489936629, Lot Number: 22HBI624; g. RECTAL, Item Number: DYNJ901758G, Case UDI/GTIN: 40193489979696, Unit UDI/GTIN: 10193489979695, Lot Number: 22JBQ935; h. BREAST, Item Number: DYNJ905525C, Case UDI/GTIN: 40195327122943, Unit UDI/GTIN: 10195327122942, Lot Number: 22JMF862,22HMH312; i. BREAST, Item Number: DYNJ906000B, Case UDI/GTIN: 40195327092697, Unit UDI/GTIN: 10195327092696, Lot Number: 22IBR879;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 11 of 38

Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL

Z-1070-2023
Recall number
Z-1070-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
174 cases (750 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. ORAL SURGERY PACK-LF, Item Number: DYNJ20491N, Case UDI/GTIN: 40195327024582, Unit UDI/GTIN: 10195327024581, Lot Number: 22IDA002; b. EXTRACTION PACK, Item Number: DYNJ49329F, Case UDI/GTIN: 40195327059638, Unit UDI/GTIN: 10195327059637, Lot Number: 22HBR730; c. ORAL SURGERY PACK, Item Number: DYNJ52404G, Case UDI/GTIN: 40195327222612, Unit UDI/GTIN: 10195327222611, Lot Number: 22IDA539,22HDB737; d. DENTAL MINOR PACK, Item Number: DYNJ83140, Case UDI/GTIN: 40195327232956, Unit UDI/GTIN: 10195327232955, Lot Number: 22JBN386; e. ORAL, Item Number: DYNJ902377G, Case UDI/GTIN: 40195327224746, Unit UDI/GTIN: 10195327224745, Lot Number: 22KBG529,22JBO834;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 12 of 38

Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY

Z-1071-2023
Recall number
Z-1071-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
86 cases (152 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. RHINOPLASTY PACK, Item Number: DYNJ27333F, Case UDI/GTIN: 40888277055293, Unit UDI/GTIN: 10888277055292, Lot Number: 22JMD960; b. OSC OTOLOGY PACK-LF, Item Number: DYNJ37384D, Case UDI/GTIN: 40193489306898, Unit UDI/GTIN: 10193489306897, Lot Number: 22HBY172; c. RHYZOTOMY, Item Number: DYNJ902288G, Case UDI/GTIN: 40193489885126, Unit UDI/GTIN: 10193489885125, Lot Number: 22JBU356,22JBT657;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 13 of 38

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO GPAD oooooo. ENT PACK pppppp. HEAD & NECK PACK qqqqqq. NASAL PACK rrrrrr. ENT PACK ssssss. ENT PACK tttttt. ENT PACK uuuuuu. ENT PACK vvvvvv. ENT PACK-LF wwwwww. ENT I-LF xxxxxx. MAJOR HEAD AND NECK PACK yyyyyy. HEAD AND NECK PACK zzzzzz. FACE AND NECK aaaaaaa. ENT PACK bbbbbbb. ENT PACK ccccccc. ENT BASIC PACK-LF ddddddd. ENT PACK-LF eeeeeee. PK, ENT-H&N fffffff. ENT PACK ggggggg. SPRINGS HEAD AND NECK PACK hhhhhhh. ENDO SINUS PACK iiiiiii. HEAD/NECK PACK jjjjjjj. ENT/SINUS PACK-LF kkkkkkk. ENT PACK lllllll. NASAL PACK mmmmmmm. ENT PACK nnnnnnn. ORAL PLASTIC FACIAL PACK ooooooo. ENT HEAD NECK PACK ppppppp. THYROIDECTOMY PACK qqqqqqq. MINOR ORL PACK rrrrrrr. EAR CUSTOM PACK sssssss. MG NS ENT PACK ttttttt. HEAD AND NECK PACK uuuuuuu. ENT PACK vvvvvvv. MAJOR ENT PACK wwwwwww. ENT xxxxxxx. NASAL EAR yyyyyyy. NASAL-LF zzzzzzz. LARGE ENT aaaaaaaa. EAR bbbbbbbb. HEAD AND NECK cccccccc. PAD ENT HEAD & NECK dddddddd. FHT CVOR TAVR eeeeeeee. MODULE NASAL NATALIE ffffffff. ENT-LF gggggggg. HEA

Z-1072-2023
Recall number
Z-1072-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
9,079 cases (27,563 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. EAR CDS-LF, Item Number: CDS982612B, Case UDI/GTIN: 40888277899729, Unit UDI/GTIN: 10888277899728, Lot Number: 22JBH351,22JBA043; b. SINUS CDS-1, Item Number: CDS982901F, Case UDI/GTIN: 40889942216971, Unit UDI/GTIN: 10889942216970, Lot Number: 22KBD129; c. ZALE FESS CDS, Item Number: CDS983178F, Case UDI/GTIN: 40195327164639, Unit UDI/GTIN: 10195327164638, Lot Number: 22JBC334,22IBC429; d. ZALE OTOLOGY CDS, Item Number: CDS983181F, Case UDI/GTIN: 40195327164646, Unit UDI/GTIN: 10195327164645, Lot Number: 22IBQ523,22IBJ058; e. ZALE HEAD & NECK CDS, Item Number: CDS983184I, Case UDI/GTIN: 40195327178353, Unit UDI/GTIN: 10195327178352, Lot Number: 22IBO795,22IBJ687; f. CUH PARA/THYROIDECTOMY CDS, Item Number: CDS983209J, Case UDI/GTIN: 40195327179794, Unit UDI/GTIN: 10195327179793, Lot Number: 22JBC280; g. CAM ENDOSCOPIC SINUS/SEPTO CDS, Item Number: CDS983499D, Case UDI/GTIN: 40193489749756, Unit UDI/GTIN: 10193489749755, Lot Number: 22IBU380,22HBW179; h. HEAD AND NECK CDS, Item Number: CDS983910K, Case UDI/GTIN: 40195327256594, Unit UDI/GTIN: 10195327256593, Lot Number: 22JBT244; i. HEAD AND NECK CDS-LF, Item Number: CDS984857J, Case UDI/GTIN: 40195327090808, Unit UDI/GTIN: 10195327090807, Lot Number: 22JDB038,22IDA739; j. NASAL, Item Number: CDS984899G, Case UDI/GTIN: 40193489983822, Unit UDI/GTIN: 10193489983821, Lot Number: 22IBC505; k. ENT SET UP CDS, Item Number: CDS985421G, Case UDI/GTIN: 40193489319300, Unit UDI/GTIN: 10193489319309, Lot Number: 22KBG050,22HBX042; l. MINOR ENT SINUS PACK-LF, Item Number: DYNJ0101278F, Case UDI/GTIN: 40193489352352, Unit UDI/GTIN: 10193489352351, Lot Number: 22HDC403; m. MAJOR EAR PACK-LF, Item Number: DYNJ0101314C, Case UDI/GTIN: 40193489451093, Unit UDI/GTIN: 10193489451092, Lot Number: 22JDA679,22HDC440; n. THORACOTOMY HARPER PACK-LF, Item Number: DYNJ0161795C, Case UDI/GTIN: 40889942216629, Unit UDI/GTIN: 10889942216628, Lot Number: 22IDB179; o. FESS NSR PACK-LF, Item Number: DYNJ0381496I, Case UDI/GTIN: 40193489475310, Unit UDI/GTIN: 10193489475319, Lot Number: 22JBH235; p. ENT BASIC PACK-LF, Item Number: DYNJ0387711D, Case UDI/GTIN: 40195327270156, Unit UDI/GTIN: 10195327270155, Lot Number: 22JMI201; q. HEAD & NECK-LF, Item Number: DYNJ04437J, Case UDI/GTIN: 40193489274494, Unit UDI/GTIN: 10193489274493, Lot Number: 22JMI207; r. ENT PACK-LF, Item Number: DYNJ04591F, Case UDI/GTIN: 40193489551434, Unit UDI/GTIN: 10193489551433, Lot Number: 22JMH877; s. SINOSCOPY-LF, Item Number: DYNJ06621D, Case UDI/GTIN: 40888277854698, Unit UDI/GTIN: 10888277854697, Lot Number: 22JBM104,22HBX999; t. MAJOR HEAD/NECK PACK-LF, Item Number: DYNJ0826705N, Case UDI/GTIN: 40193489265683, Unit UDI/GTIN: 10193489265682, Lot Number: 22JMD563,22JMD586; u. NECK PACK, Item Number: DYNJ13175, Case UDI/GTIN: 40195327215782, Unit UDI/GTIN: 10195327215781, Lot Number: 22JBG041; v. HEAD & NECK PACK, Item Number: DYNJ14069B, Case UDI/GTIN: 40884389223025, Unit UDI/GTIN: 10884389223024, Lot Number: 22JBI051,22IBQ751,22IBB059; w. HEAD & NECK TRAY, Item Number: DYNJ15653J, Case UDI/GTIN: 40193489767996, Unit UDI/GTIN: 10193489767995, Lot Number: 22JBE697; x. ENT LAW PACK-LF, Item Number: DYNJ16428L, Case UDI/GTIN: 40195327084821, Unit UDI/GTIN: 10195327084820, Lot Number: 22JMD569,22HMB943; y. ENT PACK, Item Number: DYNJ17203I, Case UDI/GTIN: 40193489668170, Unit UDI/GTIN: 10193489668179, Lot Number: 22IDB986; z. NECK PACK, Item Number: DYNJ17213D, Case UDI/GTIN: 40193489668477, Unit UDI/GTIN: 10193489668476, Lot Number: 22JDA408; aa. NASAL PACK, Item Number: DYNJ17493G, Case UDI/GTIN: 40195327224425, Unit UDI/GTIN: 10195327224424, Lot Number: 22HBR581; bb. ENT PACK, Item Number: DYNJ19846J, Case UDI/GTIN: 40888277850997, Unit UDI/GTIN: 10888277850996, Lot Number: 22IBV046; cc. FREE FLAP PACK-LF, Item Number: DYNJ20495J, Case UDI/GTIN: 40195327024407, Unit UDI/GTIN: 10195327024406, Lot Number: 22JDA143; dd. TYMPANO MASTOID, Item Number: DYNJ21567A, Case UDI/GTIN: 40080196015345, Unit UDI/GTIN: 10080196015344, Lot Number: 22JBD171,22IBE475,22HBK016; ee. MINOR HEAD & NECK #40-RF, Item Number: DYNJ21948S, Case UDI/GTIN: 40195327104727, Unit UDI/GTIN: 10195327104726, Lot Number: 22JBB180,22JBC021; ff. EAR PACK, Item Number: DYNJ22136B, Case UDI/GTIN: 40193489228220, Unit UDI/GTIN: 10193489228229, Lot Number: 22KMA168; gg. E.N.T. TRAY, Item Number: DYNJ22357K, Case UDI/GTIN: 40193489926737, Unit UDI/GTIN: 10193489926736, Lot Number: 22KBB868,22JBE605,22IBD335,22HBJ735; hh. EAR PACK-LF, Item Number: DYNJ24092M, Case UDI/GTIN: 40195327024421, Unit UDI/GTIN: 10195327024420, Lot Number: 22IDA807; ii. BASIC ENT PACK-LF, Item Number: DYNJ24912K, Case UDI/GTIN: 40193489992862, Unit UDI/GTIN: 10193489992861, Lot Number: 22IBL139,22HBV866,22HBU453,22HBT633,22HBP897; jj. PLASTIC HEAD & NECK PACK, Item Number: DYNJ24941M, Case UDI/GTIN: 40889942176329, Unit UDI/GTIN: 10889942176328, Lot Number: 22IDC167; kk. EAR TRAY #10-RF, Item Number: DYNJ27428R, Case UDI/GTIN: 40195327114900, Unit UDI/GTIN: 10195327114909, Lot Number: 22JBI743; ll. HEAD & NECK ENT PACK-RF-LF, Item Number: DYNJ30604P, Case UDI/GTIN: 40193489962834, Unit UDI/GTIN: 10193489962833, Lot Number: 22IBU329,22IBU962; mm. ENT PACK, Item Number: DYNJ30988C, Case UDI/GTIN: 40889942715719, Unit UDI/GTIN: 10889942715718, Lot Number: 22IBI164; nn. ENT PACK-LF, Item Number: DYNJ31584I, Case UDI/GTIN: 40193489504416, Unit UDI/GTIN: 10193489504415, Lot Number: 22JME741,22IMG343; oo. NASAL/SEPTO PACK, Item Number: DYNJ32099, Case UDI/GTIN: 40884389092911, Unit UDI/GTIN: 10884389092910, Lot Number: 22KBA569; pp. OSC FACE LIFT PK, Item Number: DYNJ32855B, Case UDI/GTIN: 40889942465218, Unit UDI/GTIN: 10889942465217, Lot Number: 22IBH454; qq. RRMC NASAL PACK, Item Number: DYNJ33396G, Case UDI/GTIN: 40193489914574, Unit UDI/GTIN: 10193489914573, Lot Number: 22JMD009; rr. ENT PACK, Item Number: DYNJ33698D, Case UDI/GTIN: 40889942689355, Unit UDI/GTIN: 10889942689354, Lot Number: 22JBY709,22IBF415; ss. HENRYS ENT PACK, Item Number: DYNJ34093F, Case UDI/GTIN: 40193489274685, Unit UDI/GTIN: 10193489274684, Lot Number: 22JMC221; tt. ENT, Item Number: DYNJ34426I, Case UDI/GTIN: 40193489224703, Unit UDI/GTIN: 10193489224702, Lot Number: 22JMA985; uu. FACE AND NASAL PACK, Item Number: DYNJ35554B, Case UDI/GTIN: 40195327097869, Unit UDI/GTIN: 10195327097868, Lot Number: 22IBQ641; vv. NASAL PACK, Item Number: DYNJ35803A, Case UDI/GTIN: 40889942557210, Unit UDI/GTIN: 10889942557219, Lot Number: 22JBE657; ww. ENT PACK, Item Number: DYNJ36516, Case UDI/GTIN: 40884389544113, Unit UDI/GTIN: 10884389544112, Lot Number: 22HBS907; xx. SINUS ENDOSCOPY-LF, Item Number: DYNJ36720D, Case UDI/GTIN: 40195327148684, Unit UDI/GTIN: 10195327148683, Lot Number: 22JBA686; yy. OSC NASAL-NOSE PACK-LF, Item Number: DYNJ37383C, Case UDI/GTIN: 40889942465256, Unit UDI/GTIN: 10889942465255, Lot Number: 22JBA361,22HBN245,22HBN978,22HBL526; zz. ENT PACK, Item Number: DYNJ38321D, Case UDI/GTIN: 40195327103591, Unit UDI/GTIN: 10195327103590, Lot Number: 22JBQ451; aaa. FES PACK - LF, Item Number: DYNJ38730C, Case UDI/GTIN: 40195327100316, Unit UDI/GTIN: 10195327100315, Lot Number: 22JMC574; bbb. HEAD AND NECK PACK, Item Number: DYNJ38880D, Case UDI/GTIN: 40193489997331, Unit UDI/GTIN: 10193489997330, Lot Number: 22JMA087; ccc. SCRIPPS SW ENT PACK, Item Number: DYNJ39829D, Case UDI/GTIN: 40195327176571, Unit UDI/GTIN: 10195327176570, Lot Number: 22IMI295,22HME428; ddd. SCRIPPS SW EAR PACK-LF, Item Number: DYNJ39858B, Case UDI/GTIN: 40195327179466, Unit UDI/GTIN: 10195327179465, Lot Number: 22JMA176; eee. HL ENT PACK, Item Number: DYNJ40360D, Case UDI/GTIN: 40889942697176, Unit UDI/GTIN: 10889942697175, Lot Number: 22JBL587,22IBS429,22IBU440; fff. CAROTID ENDARTECTOMY PK, Item Number: DYNJ40386B, Case UDI/GTIN: 40889942215769, Unit UDI/GTIN: 10889942215768, Lot Number: 22IBP925; ggg. EAR PACK, Item Number: DYNJ40401B, Case UDI/GTIN: 40193489231527, Unit UDI/GTIN: 10193489231526, Lot Number: 22JBI621,22HBS976,22HBK587; hhh. ENT FREE FLAP, Item Number: DYNJ40403D, Case UDI/GTIN: 40193489373531, Unit UDI/GTIN: 10193489373530, Lot Number: 22IBU477,22HBT008; iii. HEAD AND NECK PACK, Item Number: DYNJ40411A, Case UDI/GTIN: 40889942216094, Unit UDI/GTIN: 10889942216093, Lot Number: 22JBI783,22IBG980,22HBI781; jjj. TRACH PACK, Item Number: DYNJ40431A, Case UDI/GTIN: 40889942215691, Unit UDI/GTIN: 10889942215690, Lot Number: 22JBP822,22HBS909; kkk. HL EAR PACK, Item Number: DYNJ40560A, Case UDI/GTIN: 40889942529897, Unit UDI/GTIN: 10889942529896, Lot Number: 22HBZ367; lll. NASAL SINUS ENDO PK, Item Number: DYNJ41024C, Case UDI/GTIN: 40889942233466, Unit UDI/GTIN: 10889942233465, Lot Number: 22IBS024; mmm. ENT PACK, Item Number: DYNJ41060A, Case UDI/GTIN: 40195327025428, Unit UDI/GTIN: 10195327025427, Lot Number: 22IBQ559,22IBL826,22IBL050; nnn. HEAD AND NECK PACK, Item Number: DYNJ41270B, Case UDI/GTIN: 40193489789080, Unit UDI/GTIN: 10193489789089, Lot Number: 22JMB156,22JMB478,22JMA301; ooo. ENT PACK, Item Number: DYNJ41327C, Case UDI/GTIN: 40193489923156, Unit UDI/GTIN: 10193489923155, Lot Number: 22JBW436,22HBI717; ppp. HEAD AND NECK PACK, Item Number: DYNJ42004B, Case UDI/GTIN: 40888277918239, Unit UDI/GTIN: 10888277918238, Lot Number: 22JMC585; qqq. ASC HEAD & NECK PACK, Item Number: DYNJ42019B, Case UDI/GTIN: 40888277938329, Unit UDI/GTIN: 10888277938328, Lot Number: 22IBM163,22HBL313; rrr. ENT PACK, Item Number: DYNJ42228B, Case UDI/GTIN: 40193489878975, Unit UDI/GTIN: 10193489878974, Lot Number: 22IMB508; sss. DEACONESS HEAD AND NECK PACK, Item Number: DYNJ42242, Case UDI/GTIN: 40884389921280, Unit UDI/GTIN: 10884389921289, Lot Number: 22HBY134,22HBZ333; ttt. ENT PACK, Item Number: DYNJ42564B, Case UDI/GTIN: 40193489685047, Unit UDI/GTIN: 10193489685046, Lot Number: 22IBC952; uuu. BEC MOHS PACK, Item Number: DYNJ43111G, Case UDI/GTIN: 40195327007615, Unit UDI/GTIN: 10195327007614, Lot Number: 22JBK014; vvv. PK,ENT-EAR, Item Number: DYNJ43700A, Case UDI/GTIN: 40193489332194, Unit UDI/GTIN: 10193489332193, Lot Number: 22HBS025,22HBP684; www. SVMMC HEAD AND NECK PACK, Item Number: DYNJ43776G, Case UDI/GTIN: 40193489989718, Unit UDI/GTIN: 10193489989717, Lot Number: 22JBG530,22JBD640; xxx. PK, ENT, Item Number: DYNJ43875B, Case UDI/GTIN: 40193489427876, Unit UDI/GTIN: 10193489427875, Lot Number: 22JBM105,22IBC196; yyy. HEAD AND NECK PACK, Item Number: DYNJ44019B, Case UDI/GTIN: 40193489795081, Unit UDI/GTIN: 10193489795080, Lot Number: 22HBY533,22HBM204; zzz. FESS PACK, Item Number: DYNJ44080A, Case UDI/GTIN: 40888277279774, Unit UDI/GTIN: 10888277279773, Lot Number: 22IBV695; aaaa. PK,ENT-SINUS, Item Number: DYNJ45036D, Case UDI/GTIN: 40193489259903, Unit UDI/GTIN: 10193489259902, Lot Number: 22JBF806,22HBG764; bbbb. NASAL/HEAD & NECK PACK, Item Number: DYNJ45078C, Case UDI/GTIN: 40195327045204, Unit UDI/GTIN: 10195327045203, Lot Number: 22JBL812,22JBL819; cccc. ENT PACK, Item Number: DYNJ45175B, Case UDI/GTIN: 40889942485216, Unit UDI/GTIN: 10889942485215, Lot Number: 22HLA901; dddd. ENT PACK, Item Number: DYNJ45260B, Case UDI/GTIN: 40193489852449, Unit UDI/GTIN: 10193489852448, Lot Number: 22JBU804; eeee. MAJOR ENT PACK, Item Number: DYNJ45576B, Case UDI/GTIN: 40195327059201, Unit UDI/GTIN: 10195327059200, Lot Number: 22JBD150,22IBS180; ffff. ENT NECK MMC PACK, Item Number: DYNJ46091G, Case UDI/GTIN: 40193489496452, Unit UDI/GTIN: 10193489496451, Lot Number: 22HDB941; gggg. HEAD AND NECK PACK, Item Number: DYNJ46216I, Case UDI/GTIN: 40195327160341, Unit UDI/GTIN: 10195327160340, Lot Number: 22JBE614,22JBE616,22IBI293; hhhh. HEAD AND NECK PACK, Item Number: DYNJ46486B, Case UDI/GTIN: 40193489472159, Unit UDI/GTIN: 10193489472158, Lot Number: 22IBH413; iiii. HEAD AND NECK PACK, Item Number: DYNJ46509G, Case UDI/GTIN: 40195327001002, Unit UDI/GTIN: 10195327001001, Lot Number: 22HMD805; jjjj. ORAL PACK, Item Number: DYNJ46541J, Case UDI/GTIN: 40195327067909, Unit UDI/GTIN: 10195327067908, Lot Number: 22HME315; kkkk. HMT THORACOSCOPY PACK, Item Number: DYNJ47230K, Case UDI/GTIN: 40193489839259, Unit UDI/GTIN: 10193489839258, Lot Number: 22IBF197; llll. GU PACK, Item Number: DYNJ47244B, Case UDI/GTIN: 40888277896445, Unit UDI/GTIN: 10888277896444, Lot Number: 22JBE709; mmmm. HEAD NECKPACK (HNSJC)227-LF, Item Number: DYNJ47489B, Case UDI/GTIN: 40193489836821, Unit UDI/GTIN: 10193489836820, Lot Number: 22JMD474; nnnn. HEAD AND NECK PLUS I PACK, Item Number: DYNJ47635B, Case UDI/GTIN: 40193489731003, Unit UDI/GTIN: 10193489731002, Lot Number: 22HBI260; oooo. NASAL PACK, Item Number: DYNJ47753D, Case UDI/GTIN: 40193489859325, Unit UDI/GTIN: 10193489859324, Lot Number: 22IMI004; pppp. HEAD & NECK PACK-RFD-LF, Item Number: DYNJ47765J, Case UDI/GTIN: 40193489768085, Unit UDI/GTIN: 10193489768084, Lot Number: 22IMG240,22HMD477; qqqq. ENT PACK, Item Number: DYNJ47847C, Case UDI/GTIN: 40889942234296, Unit UDI/GTIN: 10889942234295, Lot Number: 22HBM628; rrrr. ENT/H&N PACK, Item Number: DYNJ48442D, Case UDI/GTIN: 40888277764508, Unit UDI/GTIN: 10888277764507, Lot Number: 22HMC400; ssss. C-SECTION PACK, Item Number: DYNJ48455A, Case UDI/GTIN: 40889942754497, Unit UDI/GTIN: 10889942754496, Lot Number: 22HBR925,22HBR422,22HBG075; tttt. ENT PACK, Item Number: DYNJ48595, Case UDI/GTIN: 40888277915184, Unit UDI/GTIN: 10888277915183, Lot Number: 22JBE666; uuuu. ENT PACK, Item Number: DYNJ48856D, Case UDI/GTIN: 40889942975472, Unit UDI/GTIN: 10889942975471, Lot Number: 22IBC410,22HBX258; vvvv. ENT PACK, Item Number: DYNJ48856F, Case UDI/GTIN: 40195327260188, Unit UDI/GTIN: 10195327260187, Lot Number: 22JBC693; wwww. NASAL ENT PACK, Item Number: DYNJ49356, Case UDI/GTIN: 40888277846785, Unit UDI/GTIN: 10888277846784, Lot Number: 22IBF462,22IBB028; xxxx. SINUS PACK, Item Number: DYNJ50110B, Case UDI/GTIN: 40889942794943, Unit UDI/GTIN: 10889942794942, Lot Number: 22HME087; yyyy. HEAD/NECK PACK, Item Number: DYNJ50297A, Case UDI/GTIN: 40889942302582, Unit UDI/GTIN: 10889942302581, Lot Number: 22IBK191,22HBZ267; zzzz. ENT PACK, Item Number: DYNJ50502G, Case UDI/GTIN: 40888277765901, Unit UDI/GTIN: 10888277765900, Lot Number: 22JBF009,22JBD205,22HBR406; aaaaa. NASAL PACK, Item Number: DYNJ50533C, Case UDI/GTIN: 40193489896764, Unit UDI/GTIN: 10193489896763, Lot Number: 22HBM477; bbbbb. FESS PACK, Item Number: DYNJ50596B, Case UDI/GTIN: 40193489864909, Unit UDI/GTIN: 10193489864908, Lot Number: 22IBK682; ccccc. NASAL SEPTOPLASTY PACK, Item Number: DYNJ50960I, Case UDI/GTIN: 40195327065639, Unit UDI/GTIN: 10195327065638, Lot Number: 22HBP168; ddddd. ENT PACK, Item Number: DYNJ51934A, Case UDI/GTIN: 40193489584777, Unit UDI/GTIN: 10193489584776, Lot Number: 22JMG827; eeeee. HEAD&NECK, Item Number: DYNJ52015, Case UDI/GTIN: 40889942233077, Unit UDI/GTIN: 10889942233076, Lot Number: 22IBL671; fffff. EAR PACK-LF, Item Number: DYNJ52043B, Case UDI/GTIN: 40195327096305, Unit UDI/GTIN: 10195327096304, Lot Number: 22JBV651; ggggg. HEAD AND NECK PACK-LF, Item Number: DYNJ52047B, Case UDI/GTIN: 40195327096060, Unit UDI/GTIN: 10195327096069, Lot Number: 22JBL899; hhhhh. EAR BASIC PACK, Item Number: DYNJ52099G, Case UDI/GTIN: 40195327035250, Unit UDI/GTIN: 10195327035259, Lot Number: 22JBW666,22JBH682; iiiii. HEAD AND NECK PACK, Item Number: DYNJ52101D, Case UDI/GTIN: 40195327079902, Unit UDI/GTIN: 10195327079901, Lot Number: 22IBR398; jjjjj. ENT/SEPTO PACK, Item Number: DYNJ52102C, Case UDI/GTIN: 40195327035267, Unit UDI/GTIN: 10195327035266, Lot Number: 22IBK213,22HBT012; kkkkk. ENT PACK, Item Number: DYNJ52641C, Case UDI/GTIN: 40195327125548, Unit UDI/GTIN: 10195327125547, Lot Number: 22JME346,22CBY373; lllll. HEAD & NECK PACK, Item Number: DYNJ52758F, Case UDI/GTIN: 40193489929479, Unit UDI/GTIN: 10193489929478, Lot Number: 22HBX064,22HBR162; mmmmm. HEAD AND NECK PACK, Item Number: DYNJ52867C, Case UDI/GTIN: 40195327048137, Unit UDI/GTIN: 10195327048136, Lot Number: 22IBQ656; nnnnn. ENT PACK, Item Number: DYNJ53413, Case UDI/GTIN: 40889942421085, Unit UDI/GTIN: 10889942421084, Lot Number: 22KBA262; ooooo. ENT PACK-LF, Item Number: DYNJ54443C, Case UDI/GTIN: 40889942925637, Unit UDI/GTIN: 10889942925636, Lot Number: 22IBG086; ppppp. ENT PACK-LF, Item Number: DYNJ54911B, Case UDI/GTIN: 40193489317054, Unit UDI/GTIN: 10193489317053, Lot Number: 22JBK448,22IBO920,22HBR955; qqqqq. HL DR PETERS ENT PACK, Item Number: DYNJ55161, Case UDI/GTIN: 40889942530640, Unit UDI/GTIN: 10889942530649, Lot Number: 22JBQ711,22IBL566; rrrrr. RHINO/SEPTO/FESS PACK, Item Number: DYNJ55955F, Case UDI/GTIN: 40195327023660, Unit UDI/GTIN: 10195327023669, Lot Number: 22IBB402,22HBU443; sssss. HEAD & NECK, Item Number: DYNJ56352D, Case UDI/GTIN: 40193489891417, Unit UDI/GTIN: 10193489891416, Lot Number: 22HMF122; ttttt. THYROID/PARATHYROID PACK, Item Number: DYNJ56989B, Case UDI/GTIN: 40193489997423, Unit UDI/GTIN: 10193489997422, Lot Number: 22IDB856; uuuuu. HEAD AND NECK MINOR PACK, Item Number: DYNJ57500A, Case UDI/GTIN: 40193489997386, Unit UDI/GTIN: 10193489997385, Lot Number: 22JBG027,22JBD520,22JBE591; vvvvv. PK,ENT, Item Number: DYNJ57583, Case UDI/GTIN: 40889942755333, Unit UDI/GTIN: 10889942755332, Lot Number: 22IBF900; wwwww. ENT PACK, Item Number: DYNJ57639A, Case UDI/GTIN: 40193489985055, Unit UDI/GTIN: 10193489985054, Lot Number: 22JMC352; xxxxx. ENT PACK, Item Number: DYNJ58613, Case UDI/GTIN: 40889942872207, Unit UDI/GTIN: 10889942872206, Lot Number: 22HBU133; yyyyy. ENT PACK, Item Number: DYNJ58955, Case UDI/GTIN: 40889942913290, Unit UDI/GTIN: 10889942913299, Lot Number: 22JMF041; zzzzz. ENT NECK PACK, Item Number: DYNJ59339B, Case UDI/GTIN: 40193489912402, Unit UDI/GTIN: 10193489912401, Lot Number: 22HMC555; aaaaaa. ENT PACK, Item Number: DYNJ59447A, Case UDI/GTIN: 40193489707664, Unit UDI/GTIN: 10193489707663, Lot Number: 22IBE517; bbbbbb. NECK PACK, Item Number: DYNJ60653A, Case UDI/GTIN: 40195327100286, Unit UDI/GTIN: 10195327100285, Lot Number: 22HME148; cccccc. EAR TRAY, Item Number: DYNJ60743F, Case UDI/GTIN: 40193489221443, Unit UDI/GTIN: 10193489221442, Lot Number: 22IBD747; dddddd. HEAD & NECK PACK, Item Number: DYNJ61295B, Case UDI/GTIN: 40193489809139, Unit UDI/GTIN: 10193489809138, Lot Number: 22HBN475; eeeeee. HEAD & NECK PACK, Item Number: DYNJ61295C, Case UDI/GTIN: 40195327246915, Unit UDI/GTIN: 10195327246914, Lot Number: 22IBH189; ffffff. MHPB HEAD AND NECK PACK, Item Number: DYNJ62032B, Case UDI/GTIN: 40195327058280, Unit UDI/GTIN: 10195327058289, Lot Number: 22JBC723,22HBR741; gggggg. NASAL PACK, Item Number: DYNJ62057C, Case UDI/GTIN: 40195327038503, Unit UDI/GTIN: 10195327038502, Lot Number: 22JBW712; hhhhhh. ENT PACK, Item Number: DYNJ62476B, Case UDI/GTIN: 40193489899796, Unit UDI/GTIN: 10193489899795, Lot Number: 22HBY505; iiiiii. JHOC EAR TRAY, Item Number: DYNJ62763A, Case UDI/GTIN: 40193489755955, Unit UDI/GTIN: 10193489755954, Lot Number: 22JBG830; jjjjjj. JHOC HEAD TRAY, Item Number: DYNJ62764A, Case UDI/GTIN: 40193489755962, Unit UDI/GTIN: 10193489755961, Lot Number: 22IBR805,22HBY155; kkkkkk. ENT I, Item Number: DYNJ63781A, Case UDI/GTIN: 40195327213115, Unit UDI/GTIN: 10195327213114, Lot Number: 22HMC704; llllll. ENT SHARED, Item Number: DYNJ64782B, Case UDI/GTIN: 40195327217700, Unit UDI/GTIN: 10195327217709, Lot Number: 22JDB161,22HDC318; mmmmmm. ENT PACK, Item Number: DYNJ66178B, Case UDI/GTIN: 40193489986342, Unit UDI/GTIN: 10193489986341, Lot Number: 22JBE823,22HBM481; nnnnnn. EENT SPLIT PACK-NO GPAD, Item Number: DYNJ66249, Case UDI/GTIN: 40193489324755, Unit UDI/GTIN: 10193489324754, Lot Number: 22JBY465; oooooo. ENT PACK, Item Number: DYNJ66379, Case UDI/GTIN: 40193489347693, Unit UDI/GTIN: 10193489347692, Lot Number: 22HMF906; pppppp. HEAD & NECK PACK, Item Number: DYNJ66399, Case UDI/GTIN: 40193489351430, Unit UDI/GTIN: 10193489351439, Lot Number: 22HBO944; qqqqqq. NASAL PACK, Item Number: DYNJ66514, Case UDI/GTIN: 40193489359283, Unit UDI/GTIN: 10193489359282, Lot Number: 22JBG484; rrrrrr. ENT PACK, Item Number: DYNJ66570, Case UDI/GTIN: 40193489360630, Unit UDI/GTIN: 10193489360639, Lot Number: 22IBU414; ssssss. ENT PACK, Item Number: DYNJ67751B, Case UDI/GTIN: 40195327029686, Unit UDI/GTIN: 10195327029685, Lot Number: 22JMF955; tttttt. ENT PACK, Item Number: DYNJ67775A, Case UDI/GTIN: 40193489996259, Unit UDI/GTIN: 10193489996258, Lot Number: 22HBU117; uuuuuu. ENT PACK, Item Number: DYNJ67824A, Case UDI/GTIN: 40193489495004, Unit UDI/GTIN: 10193489495003, Lot Number: 22IBR987; vvvvvv. ENT PACK-LF, Item Number: DYNJ67992, Case UDI/GTIN: 40193489462624, Unit UDI/GTIN: 10193489462623, Lot Number: 22IBJ809,22HBM177; wwwwww. ENT I-LF, Item Number: DYNJ68364A, Case UDI/GTIN: 40195327024513, Unit UDI/GTIN: 10195327024512, Lot Number: 22JBE689; xxxxxx. MAJOR HEAD AND NECK PACK, Item Number: DYNJ68819A, Case UDI/GTIN: 40195327159536, Unit UDI/GTIN: 10195327159535, Lot Number: 22HBN411; yyyyyy. HEAD AND NECK PACK, Item Number: DYNJ68872A, Case UDI/GTIN: 40195327181391, Unit UDI/GTIN: 10195327181390, Lot Number: 22JBO613; zzzzzz. FACE AND NECK, Item Number: DYNJ69446A, Case UDI/GTIN: 40195327264810, Unit UDI/GTIN: 10195327264819, Lot Number: 22KBA528; aaaaaaa. ENT PACK, Item Number: DYNJ69486, Case UDI/GTIN: 40193489948579, Unit UDI/GTIN: 10193489948578, Lot Number: 22HME759; bbbbbbb. ENT PACK, Item Number: DYNJ69558A, Case UDI/GTIN: 40195327225170, Unit UDI/GTIN: 10195327225179, Lot Number: 22IBP115,22HBT948; ccccccc. ENT BASIC PACK-LF, Item Number: DYNJ69587A, Case UDI/GTIN: 40195327040391, Unit UDI/GTIN: 10195327040390, Lot Number: 22HME707; ddddddd. ENT PACK-LF, Item Number: DYNJ69688, Case UDI/GTIN: 40193489969871, Unit UDI/GTIN: 10193489969870, Lot Number: 22JBE810,22HBI625; eeeeeee. PK, ENT-H&N, Item Number: DYNJ69851, Case UDI/GTIN: 40193489985857, Unit UDI/GTIN: 10193489985856, Lot Number: 22JME416,22HMH023; fffffff. ENT PACK, Item Number: DYNJ69890A, Case UDI/GTIN: 40195327235124, Unit UDI/GTIN: 10195327235123, Lot Number: 22IBR761,22HBU119; ggggggg. SPRINGS HEAD AND NECK PACK, Item Number: DYNJ69930, Case UDI/GTIN: 40193489997775, Unit UDI/GTIN: 10193489997774, Lot Number: 22IMI536,22HME709; hhhhhhh. ENDO SINUS PACK, Item Number: DYNJ69950A, Case UDI/GTIN: 40195327175703, Unit UDI/GTIN: 10195327175702, Lot Number: 22IBO306; iiiiiii. HEAD/NECK PACK, Item Number: DYNJ81402, Case UDI/GTIN: 40195327116768, Unit UDI/GTIN: 10195327116767, Lot Number: 22JBT150,22EBF640; jjjjjjj. ENT/SINUS PACK-LF, Item Number: DYNJ81820, Case UDI/GTIN: 40195327147250, Unit UDI/GTIN: 10195327147259, Lot Number: 22JBX949; kkkkkkk. ENT PACK, Item Number: DYNJ82137, Case UDI/GTIN: 40195327176670, Unit UDI/GTIN: 10195327176679, Lot Number: 22HBF358; lllllll. NASAL PACK, Item Number: DYNJ82476, Case UDI/GTIN: 40195327197217, Unit UDI/GTIN: 10195327197216, Lot Number: 22HBR242; mmmmmmm. ENT PACK, Item Number: DYNJ82492, Case UDI/GTIN: 40195327197484, Unit UDI/GTIN: 10195327197483, Lot Number: 22JBR187,22HBF736; nnnnnnn. ORAL PLASTIC FACIAL PACK, Item Number: DYNJ82506, Case UDI/GTIN: 40195327198313, Unit UDI/GTIN: 10195327198312, Lot Number: 22HBI367; ooooooo. ENT HEAD NECK PACK, Item Number: DYNJ82508, Case UDI/GTIN: 40195327198337, Unit UDI/GTIN: 10195327198336, Lot Number: 22HBH557; ppppppp. THYROIDECTOMY PACK, Item Number: DYNJ82520, Case UDI/GTIN: 40195327198368, Unit UDI/GTIN: 10195327198367, Lot Number: 22IBF364; qqqqqqq. MINOR ORL PACK, Item Number: DYNJ82563, Case UDI/GTIN: 40195327197996, Unit UDI/GTIN: 10195327197995, Lot Number: 22HBR212; rrrrrrr. EAR CUSTOM PACK, Item Number: DYNJ82564, Case UDI/GTIN: 40195327198009, Unit UDI/GTIN: 10195327198008, Lot Number: 22HBQ040; sssssss. MG NS ENT PACK, Item Number: DYNJ82590, Case UDI/GTIN: 40195327198818, Unit UDI/GTIN: 10195327198817, Lot Number: 22HBS185; ttttttt. HEAD AND NECK PACK, Item Number: DYNJ82641, Case UDI/GTIN: 40195327199402, Unit UDI/GTIN: 10195327199401, Lot Number: 22IBF695; uuuuuuu. ENT PACK, Item Number: DYNJ83139, Case UDI/GTIN: 40195327233717, Unit UDI/GTIN: 10195327233716, Lot Number: 22JBV408; vvvvvvv. MAJOR ENT PACK, Item Number: DYNJ83214, Case UDI/GTIN: 40195327245550, Unit UDI/GTIN: 10195327245559, Lot Number: 22JMD344; wwwwwww. ENT, Item Number: DYNJ901051F, Case UDI/GTIN: 40195327110803, Unit UDI/GTIN: 10195327110802, Lot Number: 22JBR735,22JBD787; xxxxxxx. NASAL EAR, Item Number: DYNJ901679F, Case UDI/GTIN: 40193489812238, Unit UDI/GTIN: 10193489812237, Lot Number: 22JBQ036; yyyyyyy. NASAL-LF, Item Number: DYNJ901749F, Case UDI/GTIN: 40193489604352, Unit UDI/GTIN: 10193489604351, Lot Number: 22IDB506; zzzzzzz. LARGE ENT, Item Number: DYNJ901761J, Case UDI/GTIN: 40195327091447, Unit UDI/GTIN: 10195327091446, Lot Number: 22KBE703,22JBA939,22IBS612; aaaaaaaa. EAR, Item Number: DYNJ901779J, Case UDI/GTIN: 40193489979740, Unit UDI/GTIN: 10193489979749, Lot Number: 22JBY312,22JBY313,22IBS613; bbbbbbbb. HEAD AND NECK, Item Number: DYNJ902108K, Case UDI/GTIN: 40193489969017, Unit UDI/GTIN: 10193489969016, Lot Number: 22IBP777; cccccccc. PAD ENT HEAD & NECK, Item Number: DYNJ902152F, Case UDI/GTIN: 40195327149216, Unit UDI/GTIN: 10195327149215, Lot Number: 22JBR424,22JBH326,22IBA638; dddddddd. FHT CVOR TAVR, Item Number: DYNJ902475B, Case UDI/GTIN: 40193489491471, Unit UDI/GTIN: 10193489491470, Lot Number: 22JBK902,22JBB350,22JBA002; eeeeeeee. MODULE NASAL NATALIE, Item Number: DYNJ903036I, Case UDI/GTIN: 40193489490092, Unit UDI/GTIN: 10193489490091, Lot Number: 22HBX971; ffffffff. ENT-LF, Item Number: DYNJ903253A, Case UDI/GTIN: 40889942632412, Unit UDI/GTIN: 10889942632411, Lot Number: 22JBW371; gggggggg. HEAD & NECK, Item Number: DYNJ903325L, Case UDI/GTIN: 40195327236473, Unit UDI/GTIN: 10195327236472, Lot Number: 22JBE300; hhhhhhhh. NASAL, Item Number: DYNJ903326J, Case UDI/GTIN: 40195327236480, Unit UDI/GTIN: 10195327236489, Lot Number: 22JBA437; iiiiiiii. HEAD & NECK, Item Number: DYNJ903472G, Case UDI/GTIN: 40195327146024, Unit UDI/GTIN: 10195327146023, Lot Number: 22KDA220; jjjjjjjj. T&A, Item Number: DYNJ903491G, Case UDI/GTIN: 40195327175598, Unit UDI/GTIN: 10195327175597, Lot Number: 22JDB890; kkkkkkkk. ENT HEAD & NECK, Item Number: DYNJ903679F, Case UDI/GTIN: 40195327182909, Unit UDI/GTIN: 10195327182908, Lot Number: 22HBT245,22HBR343; llllllll. HEAD AND NECK, Item Number: DYNJ903810C, Case UDI/GTIN: 40193489274135, Unit UDI/GTIN: 10193489274134, Lot Number: 22JBR487; mmmmmmmm. GENERAL THYROID, Item Number: DYNJ903998M, Case UDI/GTIN: 40195327220885, Unit UDI/GTIN: 10195327220884, Lot Number: 22IDB065; nnnnnnnn. ENT, Item Number: DYNJ904092C, Case UDI/GTIN: 40193489621717, Unit UDI/GTIN: 10193489621716, Lot Number: 22JDA348; oooooooo. HEAD AND NECK, Item Number: DYNJ904283B, Case UDI/GTIN: 40195327170241, Unit UDI/GTIN: 10195327170240, Lot Number: 22KBC286; pppppppp. ENT, Item Number: DYNJ904352D, Case UDI/GTIN: 40193489913478, Unit UDI/GTIN: 10193489913477, Lot Number: 22HBT177; qqqqqqqq. HEART, Item Number: DYNJ905208A, Case UDI/GTIN: 40889942910008, Unit UDI/GTIN: 10889942910007, Lot Number: 22JBQ793; rrrrrrrr. NASAL PACK, Item Number: DYNJ905563A, Case UDI/GTIN: 40193489800365, Unit UDI/GTIN: 10193489800364, Lot Number: 22KBD093; ssssssss. SINUS, Item Number: DYNJ905843D, Case UDI/GTIN: 40195327081066, Unit UDI/GTIN: 10195327081065, Lot Number: 22JBR673,22JBK495; tttttttt. HEAD&NECK, Item Number: DYNJ906948A, Case UDI/GTIN: 40195327128273, Unit UDI/GTIN: 10195327128272, Lot Number: 22JBP985,22IBE696; uuuuuuuu. ENT, Item Number: DYNJ907318, Case UDI/GTIN: 40193489387699, Unit UDI/GTIN: 10193489387698, Lot Number: 22HBS474,22HBN631; vvvvvvvv. EAR, Item Number: DYNJ907924C, Case UDI/GTIN: 40195327240029, Unit UDI/GTIN: 10195327240028, Lot Number: 22JBQ062,22HBW267; wwwwwwww. EENT, Item Number: DYNJ907925B, Case UDI/GTIN: 40195327173181, Unit UDI/GTIN: 10195327173180, Lot Number: 22JBL421,22JBK767,22JBE516,22IBI257,22HBR344; xxxxxxxx. EAR, Item Number: DYNJ909049, Case UDI/GTIN: 40195327257782, Unit UDI/GTIN: 10195327257781, Lot Number: 22JBR831,22JBE934; yyyyyyyy. ENT I-LF, Item Number: DYNJS0702, Case UDI/GTIN: 40080196798729, Unit UDI/GTIN: 10080196798728, Lot Number: 22JBH268,22IBN852,22IBF769; zzzzzzzz. ENT II-LF, Item Number: DYNJS0703, Case UDI/GTIN: 40080196597520, Unit UDI/GTIN: 10080196597529, Lot Number: 22JBJ174,22IBG858,22HBN515; aaaaaaaaa. HEAD AND NECK PACK, Item Number: DYNJS3068, Case UDI/GTIN: 40888277058294, Unit UDI/GTIN: 10888277058293, Lot Number: 22JBH755,22HBQ646; bbbbbbbbb. HEAD AND NECK PPH STD PACK-LF, Item Number: PHS184745F, Case UDI/GTIN: 40193489636681, Unit UDI/GTIN: 10193489636680, Lot Number: 22HBV665; ccccccccc. ENT PACK-LF, Item Number: PHS408470C, Case UDI/GTIN: 40195327126330, Unit UDI/GTIN: 10195327126339, Lot Number: 22HBF930; ddddddddd. ENT PACK-LF, Item Number: PHS408470D, Case UDI/GTIN: 40195327250639, Unit UDI/GTIN: 10195327250638, Lot Number: 22IBQ906

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 14 of 38

Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

Z-1073-2023
Recall number
Z-1073-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
237 cases (1,242 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. MINOR/BREAST BIOPSY-LF, Item Number: DYNJS3035, Case UDI/GTIN: 40884389421926, Unit UDI/GTIN: 10884389421925, Lot Number: 22IBK248,22IBB171,22HBM446; b. BREAST BIOPSY-LF, Item Number: DYNJT1911D, Case UDI/GTIN: 40888277808967, Unit UDI/GTIN: 10888277808966, Lot Number: 22JBG862,22HBV267

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 15 of 38

Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k. LAP CHOLE CDS l. GENERAL LAPAROSCOPY CDS m. MINOR PROCEDURE CDS n. MAJOR CDS o. HERNIA CDS p. MINOR CDS q. MAJOR PROCEDURE CDS r. LAP GASTRIC BYPASS CDS UCC s. GENERAL LAPAROSCOPY CDS t. LAP CHOLE CDS u. CUH MAJOR PROCEDURE CDS v. LAPAROSCOPIC CDS-LF w. GENERAL LAPAROSCOPY CDS-LF x. MAJOR ABDOMINAL CDS y. LAP CHOLE CDS z. GENERAL SURGERY CDS aa. MAJOR ABDOMINAL/GENERAL-LF bb. LAP CHOLE/LAPAROSCOPIC ABD-LF cc. GENERAL LAPAROSCOPY CDS dd. LAPAROSCOPY CDS ee. GENERAL LAPAROSCOPY CDS ff. LAP CHOLE CDS UCC-LF gg. GENERAL LAPAROSCOPY CDS hh. LAPAROSCOPY CDS ii. BARIATRIC PROCEDURE jj. MINOR SURGERY CDS kk. LAP CHOLE CDS ll. ACH MINOR PROCEDURE mm. ACH MINOR PROCEDURE nn. ACH MAJOR ABDOMINAL oo. GENERAL LAPAROSCOPY pp. LAP COLECTOMY PACK-LF qq. MINOR PROCEDURE PACK-LF rr. OPERATIVE LAPAROSCOPY PACK-LF ss. LAP CHOLE PACK-LF tt. MAJOR PROCEDURE PACK-LF uu. GYN MAJOR ABDOMINAL PACK-LF vv. MAJOR ABDOMINAL HARPER PACK-LF ww. LAPAROTOMY PACK-LF xx. LAPAROTOMY PACK-LF yy. MINOR PACK-LF zz. MINOR PROCEDURE PACK-LF aaa. LAP CHOLE PACK bbb. LAP APPY PACK ccc. LAP APPY PACK ddd. OPEN HERNIA APPY PACK eee. LAP CHOLE PACK-LF fff. LAP CHOLE PACK-LF ggg. LAPAROSCOPY PACK-LF hhh. MINOR PACK-LF iii. LAPAROTOMY BASIC PACK-LF jjj. LAP CHOLE PACK-LF kkk. MINOR PACK-LF lll. LAPAROSCOPIC - UNIV mmm. KIDNEY - UNIV nnn. LAP CHOLE PACK-LF ooo. LASER LAP PACK ppp. LAP CHOLE PACK-LF qqq. MAJOR LAPAROTOMY PACK-LF rrr. LAP CHOLE PACK-LF sss. MINOR PACK-LF ttt. MAJOR ABDOMINAL PACK-LF uuu. DAVINCI PACK-LF vvv. LAP CHOLE PACK www. LAPAROSCOPY PACK-GYN xxx. LAP CHOLE PACK yyy. MINOR PACK zzz. LAP CHOLE PACK-LF aaaa. MAJOR PACK bbbb. LAP CHOLE PACK-LF cccc. LAPAROSCOPY PACK-LF dddd. LAPAROSCOPY PACK-LF eeee. MINOR PACK-LF ffff. LAP CHOLE III-LF gggg. ROBOTICS PACK-LF hhhh. MINOR PACK iiii. PELVIC LAPAROSCOPY PACK-LF jjjj. LAP CHOLE PACK-LF kkkk. UNIVERSAL LAPAROSCOPY PACK-LF llll. LAPAROSCOPY PACK mmmm. LAPAROTOMY PACK-LF nnnn. LAPCHOLE II PACK-LF oooo. LAP CHOLE PACK-LF pppp. MINOR PACK-LF qqqq. MAJOR LAP PACK-LF rrrr. MINOR PROCEDURE CUSTOM PACK-LF ssss. MINOR PACK-LF tttt. LAPAROSCOPY PACK-LF uuuu. MONTEFIORE MVH LAPAROTOMY PACK vvvv. MINOR PACK-LF wwww. LAPAROSCOPY PK/ALTAMONTE xxxx. LAPAROSCOPY PK yyyy. LAP CHOLE PACK-LF zzzz. PPM-ICD PACK-LF aaaaa. STANDARD PACK-LF bbbbb. LAP CHOLE PACK ccccc. LAP TRAY-LF ddddd. MINOR PACK eeeee. BARIATRIC PACK #117-RF fffff. GENERAL LAPAROSCOPY PACK ggggg. TORNETTA ACETABULUM/PE PK hhhhh. MLD PACK iiiii. LAP CHOLE TRAY-LF jjjjj. SET UP PACK-LF kkkkk. LAPAROSCOPY PACK-LF lllll. MAJOR LAPAROTOMY PACK mmmmm. MVFF/FIBU #54-RF nnnnn. MAJOR GENERAL PACK ooooo. LAPAROSCOPY PACK ppppp. MINOR PACK-LF qqqqq. LAP CHOLE TRAY rrrrr. MINOR OPEN-RF-LF sssss. LAPAROSCOPY-RF-LF ttttt. MAJOR OPEN-RF-LF uuuuu. MONTEFIORE MVH MINOR PACK vvvvv. GLENNON GENERAL MAJOR PACK-LF wwwww. LAP CHOLE PACK xxxxx. MINOR PACK-LF yyyyy. MAJOR SET UP PACK-LF zzzzz. SCC RECTAL PACK aaaaaa. MINI LAPAROTOMY #16-RF bbbbbb. LAP CHOLE PACK cccccc. LAPAROSCOPY TRAY SC-LF dddddd. MINOR PACK eeeeee. LAP CHOLE PACK ffffff. SET UP PACK gggggg. LAPAROSCOPY PACK-LF hhhhhh. GENERAL LAPAROSCOPY PACK iiiiii. MAJOR ABDOMINAL PACK jjjjjj. OSC MINOR PACK-LF kkkkkk. MINOR SURGERY PACK llllll. BASIC LAPAROTOMY mmmmmm. GENERAL RECTAL PACK-LF nnnnnn. LAP CHOLE PACK-LF oooooo. LAP CHOLE PACK pppppp. LAPAROTOMY PK qqqqqq. LAPAROSCOPIC GALLBLADDER PACK rrrrrr. LAP CHOLE ssssss. LAPAROSCOPY tttttt. LAPAROTOMY uuuuuu. MINOR PACK vvvvvv. MINOR PACK wwwwww. MAJOR PACK xxxxxx. MINOR PACK yyyyyy. PEDIATRIC LAP PACK zzzzzz. MINOR PROCEDURE PACK-LF aaaaaaa. LAPAROSCOPY PACK bbbbbbb. LAPAROSCOPY PACK-LF ccccccc. PEDIATRIC LAP PACK-LF ddddddd. MINOR PACK-LF eeeeeee. MINOR ABDOMINAL PROCEDURPK-LF fffffff. GENERAL LAPAROS

Z-1074-2023
Recall number
Z-1074-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
42,593 cases (117,470 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. LAPAROTOMY CDS-LF, Item Number: CDS860091A, Case UDI/GTIN: 40884389018324, Unit UDI/GTIN: 10884389018323, Lot Number: 22KMA029,22IMI179,22IME690; b. LAPAROSCOPY CDS-LF, Item Number: CDS860235I, Case UDI/GTIN: 40193489485210, Unit UDI/GTIN: 10193489485219, Lot Number: 22JMB557; c. BASIC LAPAROSCOPY CDS, Item Number: CDS920080S, Case UDI/GTIN: 40195327209606, Unit UDI/GTIN: 10195327209605, Lot Number: 22JBO105; d. LAPAROSCOPY CDS-LF, Item Number: CDS920126AB, Case UDI/GTIN: 40193489203296, Unit UDI/GTIN: 10193489203295, Lot Number: 22JMD700; e. GENERAL LAPAROSCOPY PROCEDURE, Item Number: CDS930125V, Case UDI/GTIN: 40195327255504, Unit UDI/GTIN: 10195327255503, Lot Number: 22JBH334,22JBA038; f. LAP CHOLE CDS, Item Number: CDS930235K, Case UDI/GTIN: 40889942108160, Unit UDI/GTIN: 10889942108169, Lot Number: 22IMD079; g. COLO-RECTAL CDS-LF, Item Number: CDS941345K, Case UDI/GTIN: 40195327062867, Unit UDI/GTIN: 10195327062866, Lot Number: 22IBT398,22HBW953; h. MAJOR PROCEDURE-LF, Item Number: CDS980255U, Case UDI/GTIN: 40195327255306, Unit UDI/GTIN: 10195327255305, Lot Number: 22JBW968; i. HYPOSPADIUS CDS, Item Number: CDS980372K, Case UDI/GTIN: 40195327251445, Unit UDI/GTIN: 10195327251444, Lot Number: 22JBV275; j. LAPAROSCOPY-GENERAL, Item Number: CDS980746I, Case UDI/GTIN: 40889942428565, Unit UDI/GTIN: 10889942428564, Lot Number: 22JBR293,22JBB178,22JBB179; k. LAP CHOLE CDS, Item Number: CDS981016D, Case UDI/GTIN: 40193489976732, Unit UDI/GTIN: 10193489976731, Lot Number: 22KBD660; l. GENERAL LAPAROSCOPY CDS, Item Number: CDS981537F, Case UDI/GTIN: 40193489995016, Unit UDI/GTIN: 10193489995015, Lot Number: 22JBU287; m. MINOR PROCEDURE CDS, Item Number: CDS981793D, Case UDI/GTIN: 40889942913603, Unit UDI/GTIN: 10889942913602, Lot Number: 22IBO676; n. MAJOR CDS, Item Number: CDS981883T, Case UDI/GTIN: 40195327144990, Unit UDI/GTIN: 10195327144999, Lot Number: 22IBV913; o. HERNIA CDS, Item Number: CDS982375I, Case UDI/GTIN: 40889942620976, Unit UDI/GTIN: 10889942620975, Lot Number: 22JBD868; p. MINOR CDS, Item Number: CDS982384F, Case UDI/GTIN: 40193489928700, Unit UDI/GTIN: 10193489928709, Lot Number: 22KMA015,22JMC842; q. MAJOR PROCEDURE CDS, Item Number: CDS982414O, Case UDI/GTIN: 40195327212347, Unit UDI/GTIN: 10195327212346, Lot Number: 22IBE734; r. LAP GASTRIC BYPASS CDS UCC, Item Number: CDS982608J, Case UDI/GTIN: 40193489861465, Unit UDI/GTIN: 10193489861464, Lot Number: 22JBJ960; s. GENERAL LAPAROSCOPY CDS, Item Number: CDS982611I, Case UDI/GTIN: 40193489321877, Unit UDI/GTIN: 10193489321876, Lot Number: 22JBE552; t. LAP CHOLE CDS, Item Number: CDS983099J, Case UDI/GTIN: 40193489362924, Unit UDI/GTIN: 10193489362923, Lot Number: 22KBE143,22JBC456; u. CUH MAJOR PROCEDURE CDS, Item Number: CDS983208J, Case UDI/GTIN: 40195327164530, Unit UDI/GTIN: 10195327164539, Lot Number: 22JBJ580,22HBW897,22HBV121; v. LAPAROSCOPIC CDS-LF, Item Number: CDS983384I, Case UDI/GTIN: 40193489863582, Unit UDI/GTIN: 10193489863581, Lot Number: 22IBQ984; w. GENERAL LAPAROSCOPY CDS-LF, Item Number: CDS983865I, Case UDI/GTIN: 40193489991698, Unit UDI/GTIN: 10193489991697, Lot Number: 22KDA310,22JDA222; x. MAJOR ABDOMINAL CDS, Item Number: CDS983908P, Case UDI/GTIN: 40195327238323, Unit UDI/GTIN: 10195327238322, Lot Number: 22IBE804; y. LAP CHOLE CDS, Item Number: CDS983912W, Case UDI/GTIN: 40195327238408, Unit UDI/GTIN: 10195327238407, Lot Number: 22IBV023; z. GENERAL SURGERY CDS, Item Number: CDS983914L, Case UDI/GTIN: 40195327238361, Unit UDI/GTIN: 10195327238360, Lot Number: 22JBR865,22JBB309; aa. MAJOR ABDOMINAL/GENERAL-LF, Item Number: CDS984534I, Case UDI/GTIN: 40193489831338, Unit UDI/GTIN: 10193489831337, Lot Number: 22KDA258,22IDB503; bb. LAP CHOLE/LAPAROSCOPIC ABD-LF, Item Number: CDS984535L, Case UDI/GTIN: 40193489903172, Unit UDI/GTIN: 10193489903171, Lot Number: 22JDB461,22IDA158; cc. GENERAL LAPAROSCOPY CDS, Item Number: CDS984624N, Case UDI/GTIN: 40195327117505, Unit UDI/GTIN: 10195327117504, Lot Number: 22JDA095; dd. LAPAROSCOPY CDS, Item Number: CDS984627G, Case UDI/GTIN: 40195327010011, Unit UDI/GTIN: 10195327010010, Lot Number: 22IBQ974,22IBP546,22IBG166,22IBB662; ee. GENERAL LAPAROSCOPY CDS, Item Number: CDS984659N, Case UDI/GTIN: 40193489433273, Unit UDI/GTIN: 10193489433272, Lot Number: 22JMA045,22IMF923; ff. LAP CHOLE CDS UCC-LF, Item Number: CDS984691G, Case UDI/GTIN: 40193489325080, Unit UDI/GTIN: 10193489325089, Lot Number: 22JBN085; gg. GENERAL LAPAROSCOPY CDS, Item Number: CDS984901K, Case UDI/GTIN: 40193489983839, Unit UDI/GTIN: 10193489983838, Lot Number: 22JBJ447,22HBX991,22HBX992; hh. LAPAROSCOPY CDS, Item Number: CDS985035J, Case UDI/GTIN: 40193489377812, Unit UDI/GTIN: 10193489377811, Lot Number: 22JMG536,22IMH123; ii. BARIATRIC PROCEDURE, Item Number: CDS985222J, Case UDI/GTIN: 40195327243280, Unit UDI/GTIN: 10195327243289, Lot Number: 22IBU334,22IBP493,22IBJ650; jj. MINOR SURGERY CDS, Item Number: CDS985321K, Case UDI/GTIN: 40195327091478, Unit UDI/GTIN: 10195327091477, Lot Number: 22JBJ072; kk. LAP CHOLE CDS, Item Number: CDS985356I, Case UDI/GTIN: 40193489766661, Unit UDI/GTIN: 10193489766660, Lot Number: 22IBN538; ll. ACH MINOR PROCEDURE, Item Number: CDS985451F, Case UDI/GTIN: 40193489847001, Unit UDI/GTIN: 10193489847000, Lot Number: 22IBJ197; mm. ACH MINOR PROCEDURE, Item Number: CDS985451G, Case UDI/GTIN: 40195327237630, Unit UDI/GTIN: 10195327237639, Lot Number: 22JBB279; nn. ACH MAJOR ABDOMINAL, Item Number: CDS985454I, Case UDI/GTIN: 40195327237647, Unit UDI/GTIN: 10195327237646, Lot Number: 22IBV475,22IBV239; oo. GENERAL LAPAROSCOPY, Item Number: CDS985542K, Case UDI/GTIN: 40193489900003, Unit UDI/GTIN: 10193489900002, Lot Number: 22IBJ353,22HBO296; pp. LAP COLECTOMY PACK-LF, Item Number: DYNJ0110043Q, Case UDI/GTIN: 40193489384308, Unit UDI/GTIN: 10193489384307, Lot Number: 22JMH165,22JMD795; qq. MINOR PROCEDURE PACK-LF, Item Number: DYNJ0160104C, Case UDI/GTIN: 40889942939115, Unit UDI/GTIN: 10889942939114, Lot Number: 22IDC059,22HDB933; rr. OPERATIVE LAPAROSCOPY PACK-LF, Item Number: DYNJ0160332C, Case UDI/GTIN: 40193489521369, Unit UDI/GTIN: 10193489521368, Lot Number: 22JDB328,22IDB923; ss. LAP CHOLE PACK-LF, Item Number: DYNJ0160396B, Case UDI/GTIN: 40889942051831, Unit UDI/GTIN: 10889942051830, Lot Number: 22JDA857,22IDC031; tt. MAJOR PROCEDURE PACK-LF, Item Number: DYNJ0160412B, Case UDI/GTIN: 40889942051862, Unit UDI/GTIN: 10889942051861, Lot Number: 22IDA623,22HDC451; uu. GYN MAJOR ABDOMINAL PACK-LF, Item Number: DYNJ0160434B, Case UDI/GTIN: 40889942051879, Unit UDI/GTIN: 10889942051878, Lot Number: 22IDB760; vv. MAJOR ABDOMINAL HARPER PACK-LF, Item Number: DYNJ0160657C, Case UDI/GTIN: 40889942219590, Unit UDI/GTIN: 10889942219599, Lot Number: 22IDB177,22IDA104; ww. LAPAROTOMY PACK-LF, Item Number: DYNJ0161299B, Case UDI/GTIN: 40889942211631, Unit UDI/GTIN: 10889942211630, Lot Number: 22JDA680,22IDA314; xx. LAPAROTOMY PACK-LF, Item Number: DYNJ0190114G, Case UDI/GTIN: 40193489357517, Unit UDI/GTIN: 10193489357516, Lot Number: 22HMD734; yy. MINOR PACK-LF, Item Number: DYNJ0200306U, Case UDI/GTIN: 40889942054139, Unit UDI/GTIN: 10889942054138, Lot Number: 22JMD278,22JMC962,22IMD663; zz. MINOR PROCEDURE PACK-LF, Item Number: DYNJ02174M, Case UDI/GTIN: 40195327210114, Unit UDI/GTIN: 10195327210113, Lot Number: 22JBI348; aaa. LAP CHOLE PACK, Item Number: DYNJ02458O, Case UDI/GTIN: 40193489952422, Unit UDI/GTIN: 10193489952421, Lot Number: 22JMI059,22IMD666; bbb. LAP APPY PACK, Item Number: DYNJ02471N, Case UDI/GTIN: 40193489934404, Unit UDI/GTIN: 10193489934403, Lot Number: 22IMA430; ccc. LAP APPY PACK, Item Number: DYNJ02471O, Case UDI/GTIN: 40195327269983, Unit UDI/GTIN: 10195327269982, Lot Number: 22JMD978,22JMD979; ddd. OPEN HERNIA APPY PACK, Item Number: DYNJ02575F, Case UDI/GTIN: 40193489957915, Unit UDI/GTIN: 10193489957914, Lot Number: 22HDB947; eee. LAP CHOLE PACK-LF, Item Number: DYNJ0259919AA, Case UDI/GTIN: 40193489506977, Unit UDI/GTIN: 10193489506976, Lot Number: 22JMF345,22JMB272; fff. LAP CHOLE PACK-LF, Item Number: DYNJ0287395T, Case UDI/GTIN: 40195327088683, Unit UDI/GTIN: 10195327088682, Lot Number: 22HBX092; ggg. LAPAROSCOPY PACK-LF, Item Number: DYNJ0364138K, Case UDI/GTIN: 40195327225729, Unit UDI/GTIN: 10195327225728, Lot Number: 22HBY161; hhh. MINOR PACK-LF, Item Number: DYNJ0365894S, Case UDI/GTIN: 40889942129479, Unit UDI/GTIN: 10889942129478, Lot Number: 22JMA517; iii. LAPAROTOMY BASIC PACK-LF, Item Number: DYNJ0367791P, Case UDI/GTIN: 40888277763341, Unit UDI/GTIN: 10888277763340, Lot Number: 22JMG112,22HMD862; jjj. LAP CHOLE PACK-LF, Item Number: DYNJ0370521P, Case UDI/GTIN: 40889942708810, Unit UDI/GTIN: 10889942708819, Lot Number: 22JMF394,22HME895; kkk. MINOR PACK-LF, Item Number: DYNJ0375013K, Case UDI/GTIN: 40889942160014, Unit UDI/GTIN: 10889942160013, Lot Number: 22JMC966,22IMB259; lll. LAPAROSCOPIC - UNIV, Item Number: DYNJ0375593L, Case UDI/GTIN: 40193489943222, Unit UDI/GTIN: 10193489943221, Lot Number: 22JBM536,22IBJ494; mmm. KIDNEY - UNIV, Item Number: DYNJ0376044N, Case UDI/GTIN: 40193489371728, Unit UDI/GTIN: 10193489371727, Lot Number: 22JBF044; nnn. LAP CHOLE PACK-LF, Item Number: DYNJ0378346L, Case UDI/GTIN: 40195327089956, Unit UDI/GTIN: 10195327089955, Lot Number: 22IBU934; ooo. LASER LAP PACK, Item Number: DYNJ0378373P, Case UDI/GTIN: 40195327089994, Unit UDI/GTIN: 10195327089993, Lot Number: 22JBD473; ppp. LAP CHOLE PACK-LF, Item Number: DYNJ0381534K, Case UDI/GTIN: 40193489475341, Unit UDI/GTIN: 10193489475340, Lot Number: 22KBA791,22JBX487; qqq. MAJOR LAPAROTOMY PACK-LF, Item Number: DYNJ0382197F, Case UDI/GTIN: 40889942434603, Unit UDI/GTIN: 10889942434602, Lot Number: 22IBI915,22HBY700; rrr. LAP CHOLE PACK-LF, Item Number: DYNJ0382240F, Case UDI/GTIN: 40889942434788, Unit UDI/GTIN: 10889942434787, Lot Number: 22JBV796,22JBE979,22JBE745,22HMC285; sss. MINOR PACK-LF, Item Number: DYNJ0384297J, Case UDI/GTIN: 40888277757272, Unit UDI/GTIN: 10888277757271, Lot Number: 22JME075,22JME079; ttt. MAJOR ABDOMINAL PACK-LF, Item Number: DYNJ0395023K, Case UDI/GTIN: 40195327064168, Unit UDI/GTIN: 10195327064167, Lot Number: 22JMF033,22JMB276; uuu. DAVINCI PACK-LF, Item Number: DYNJ0400644O, Case UDI/GTIN: 40889942708803, Unit UDI/GTIN: 10889942708802, Lot Number: 22IMG642; vvv. LAP CHOLE PACK, Item Number: DYNJ04581P, Case UDI/GTIN: 40193489555470, Unit UDI/GTIN: 10193489555479, Lot Number: 22IME569; www. LAPAROSCOPY PACK-GYN, Item Number: DYNJ04601I, Case UDI/GTIN: 40193489551472, Unit UDI/GTIN: 10193489551471, Lot Number: 22IMG644; xxx. LAP CHOLE PACK, Item Number: DYNJ04621R, Case UDI/GTIN: 40193489428347, Unit UDI/GTIN: 10193489428346, Lot Number: 22IMD127,22HMD046; yyy. MINOR PACK, Item Number: DYNJ04625M, Case UDI/GTIN: 40193489428378, Unit UDI/GTIN: 10193489428377, Lot Number: 22IMH387; zzz. LAP CHOLE PACK-LF, Item Number: DYNJ04855P, Case UDI/GTIN: 40193489303934, Unit UDI/GTIN: 10193489303933, Lot Number: 22JMA066; aaaa. MAJOR PACK, Item Number: DYNJ04875O, Case UDI/GTIN: 40195327188048, Unit UDI/GTIN: 10195327188047, Lot Number: 22IMH390; bbbb. LAP CHOLE PACK-LF, Item Number: DYNJ0508484AC, Case UDI/GTIN: 40195327047413, Unit UDI/GTIN: 10195327047412, Lot Number: 22JMC886,22HMD483; cccc. LAPAROSCOPY PACK-LF, Item Number: DYNJ0551175S, Case UDI/GTIN: 40889942826606, Unit UDI/GTIN: 10889942826605, Lot Number: 22JME042; dddd. LAPAROSCOPY PACK-LF, Item Number: DYNJ0588918X, Case UDI/GTIN: 40195327167524, Unit UDI/GTIN: 10195327167523, Lot Number: 22IMG648; eeee. MINOR PACK-LF, Item Number: DYNJ05890J, Case UDI/GTIN: 40193489948890, Unit UDI/GTIN: 10193489948899, Lot Number: 22JBP943,22IBQ595,22HBV352; ffff. LAP CHOLE III-LF, Item Number: DYNJ06364, Case UDI/GTIN: 40080196872177, Unit UDI/GTIN: 10080196872176, Lot Number: 22JDA184,22HDC074; gggg. ROBOTICS PACK-LF, Item Number: DYNJ0655936F, Case UDI/GTIN: 40195327064151, Unit UDI/GTIN: 10195327064150, Lot Number: 22JMC085,22IME217,22HME623; hhhh. MINOR PACK, Item Number: DYNJ06759B, Case UDI/GTIN: 40889942857099, Unit UDI/GTIN: 10889942857098, Lot Number: 22HME293; iiii. PELVIC LAPAROSCOPY PACK-LF, Item Number: DYNJ0682018D, Case UDI/GTIN: 40193489770248, Unit UDI/GTIN: 10193489770247, Lot Number: 22IMG333; jjjj. LAP CHOLE PACK-LF, Item Number: DYNJ0682024C, Case UDI/GTIN: 40193489770255, Unit UDI/GTIN: 10193489770254, Lot Number: 22JMC549; kkkk. UNIVERSAL LAPAROSCOPY PACK-LF, Item Number: DYNJ0696288I, Case UDI/GTIN: 40193489723244, Unit UDI/GTIN: 10193489723243, Lot Number: 22IBT105; llll. LAPAROSCOPY PACK, Item Number: DYNJ0751465AA, Case UDI/GTIN: 40195327196173, Unit UDI/GTIN: 10195327196172, Lot Number: 22JMC551; mmmm. LAPAROTOMY PACK-LF, Item Number: DYNJ0781556S, Case UDI/GTIN: 40193489226073, Unit UDI/GTIN: 10193489226072, Lot Number: 22JMC987; nnnn. LAPCHOLE II PACK-LF, Item Number: DYNJ0800013A, Case UDI/GTIN: 40193489878364, Unit UDI/GTIN: 10193489878363, Lot Number: 22IMG014; oooo. LAP CHOLE PACK-LF, Item Number: DYNJ0826593R, Case UDI/GTIN: 40193489608299, Unit UDI/GTIN: 10193489608298, Lot Number: 22JMH197; pppp. MINOR PACK-LF, Item Number: DYNJ0843776K, Case UDI/GTIN: 40195327156528, Unit UDI/GTIN: 10195327156527, Lot Number: 22JDB150; qqqq. MAJOR LAP PACK-LF, Item Number: DYNJ0843861L, Case UDI/GTIN: 40195327156542, Unit UDI/GTIN: 10195327156541, Lot Number: 22HDC475; rrrr. MINOR PROCEDURE CUSTOM PACK-LF, Item Number: DYNJ0915752X, Case UDI/GTIN: 40195327167531, Unit UDI/GTIN: 10195327167530, Lot Number: 22JBP795,22HBL101; ssss. MINOR PACK-LF, Item Number: DYNJ0922980, Case UDI/GTIN: 40889942099611, Unit UDI/GTIN: 10889942099610, Lot Number: 22JMG712,22JMG777,22HMD837; tttt. LAPAROSCOPY PACK-LF, Item Number: DYNJ0958345B, Case UDI/GTIN: 40888277795861, Unit UDI/GTIN: 10888277795860, Lot Number: 22HMF936; uuuu. MONTEFIORE MVH LAPAROTOMY PACK, Item Number: DYNJ09914G, Case UDI/GTIN: 40888277557612, Unit UDI/GTIN: 10888277557611, Lot Number: 22IBA679; vvvv. MINOR PACK-LF, Item Number: DYNJ14026B, Case UDI/GTIN: 40888277857736, Unit UDI/GTIN: 10888277857735, Lot Number: 22JBY025,22IBD146; wwww. LAPAROSCOPY PK/ALTAMONTE, Item Number: DYNJ14072B, Case UDI/GTIN: 40884389637174, Unit UDI/GTIN: 10884389637173, Lot Number: 22IBA046; xxxx. LAPAROSCOPY PK, Item Number: DYNJ14073B, Case UDI/GTIN: 40884389637167, Unit UDI/GTIN: 10884389637166, Lot Number: 22JBG061,22IBA049; yyyy. LAP CHOLE PACK-LF, Item Number: DYNJ14076C, Case UDI/GTIN: 40884389637105, Unit UDI/GTIN: 10884389637104, Lot Number: 22JBX882,22JBF502; zzzz. PPM-ICD PACK-LF, Item Number: DYNJ15949C, Case UDI/GTIN: 40888277859112, Unit UDI/GTIN: 10888277859111, Lot Number: 22JBT081,22IBT216; aaaaa. STANDARD PACK-LF, Item Number: DYNJ16616L, Case UDI/GTIN: 40195327113330, Unit UDI/GTIN: 10195327113339, Lot Number: 22JBX627,22IBN179; bbbbb. LAP CHOLE PACK, Item Number: DYNJ17386D, Case UDI/GTIN: 40193489384759, Unit UDI/GTIN: 10193489384758, Lot Number: 22IMF062; ccccc. LAP TRAY-LF, Item Number: DYNJ17388C, Case UDI/GTIN: 40889942490432, Unit UDI/GTIN: 10889942490431, Lot Number: 22JMF400,22IMB285; ddddd. MINOR PACK, Item Number: DYNJ17389G, Case UDI/GTIN: 40195327124343, Unit UDI/GTIN: 10195327124342, Lot Number: 22JMC558; eeeee. BARIATRIC PACK #117-RF, Item Number: DYNJ17415M, Case UDI/GTIN: 40195327104499, Unit UDI/GTIN: 10195327104498, Lot Number: 22JBR226,22IBC349,22HBO300; fffff. GENERAL LAPAROSCOPY PACK, Item Number: DYNJ17443R, Case UDI/GTIN: 40193489775632, Unit UDI/GTIN: 10193489775631, Lot Number: 22IBT769; ggggg. TORNETTA ACETABULUM/PE PK, Item Number: DYNJ17500J, Case UDI/GTIN: 40195327224456, Unit UDI/GTIN: 10195327224455, Lot Number: 22JBJ841; hhhhh. MLD PACK, Item Number: DYNJ19521P, Case UDI/GTIN: 40193489941198, Unit UDI/GTIN: 10193489941197, Lot Number: 22IMH831; iiiii. LAP CHOLE TRAY-LF, Item Number: DYNJ20115C, Case UDI/GTIN: 40888277861580, Unit UDI/GTIN: 10888277861589, Lot Number: 22JBD476; jjjjj. SET UP PACK-LF, Item Number: DYNJ20162A, Case UDI/GTIN: 40888277861597, Unit UDI/GTIN: 10888277861596, Lot Number: 22JBW475; kkkkk. LAPAROSCOPY PACK-LF, Item Number: DYNJ20468J, Case UDI/GTIN: 40195327024339, Unit UDI/GTIN: 10195327024338, Lot Number: 22IBS009,22HLA786; lllll. MAJOR LAPAROTOMY PACK, Item Number: DYNJ20819M, Case UDI/GTIN: 40195327191451, Unit UDI/GTIN: 10195327191450, Lot Number: 22JMI223; mmmmm. MVFF/FIBU #54-RF, Item Number: DYNJ21927R, Case UDI/GTIN: 40195327104734, Unit UDI/GTIN: 10195327104733, Lot Number: 22HBO301; nnnnn. MAJOR GENERAL PACK, Item Number: DYNJ22645N, Case UDI/GTIN: 40195327019991, Unit UDI/GTIN: 10195327019990, Lot Number: 22JMC847,22JMC865; ooooo. LAPAROSCOPY PACK, Item Number: DYNJ22701I, Case UDI/GTIN: 40193489772402, Unit UDI/GTIN: 10193489772401, Lot Number: 22JBI907; ppppp. MINOR PACK-LF, Item Number: DYNJ23036I, Case UDI/GTIN: 40889942818762, Unit UDI/GTIN: 10889942818761, Lot Number: 22JBW503,22HBR661; qqqqq. LAP CHOLE TRAY, Item Number: DYNJ24405G, Case UDI/GTIN: 40193489840590, Unit UDI/GTIN: 10193489840599, Lot Number: 22JBI146; rrrrr. MINOR OPEN-RF-LF, Item Number: DYNJ24908N, Case UDI/GTIN: 40193489962858, Unit UDI/GTIN: 10193489962857, Lot Number: 22JBW871,22IBL333; sssss. LAPAROSCOPY-RF-LF, Item Number: DYNJ24910N, Case UDI/GTIN: 40193489962865, Unit UDI/GTIN: 10193489962864, Lot Number: 22IBT816; ttttt. MAJOR OPEN-RF-LF, Item Number: DYNJ24915N, Case UDI/GTIN: 40193489962872, Unit UDI/GTIN: 10193489962871, Lot Number: 22HBV785,22HBQ660; uuuuu. MONTEFIORE MVH MINOR PACK, Item Number: DYNJ25046C, Case UDI/GTIN: 40888277557605, Unit UDI/GTIN: 10888277557604, Lot Number: 22IBR186,22IBC436; vvvvv. GLENNON GENERAL MAJOR PACK-LF, Item Number: DYNJ25741M, Case UDI/GTIN: 40195327072064, Unit UDI/GTIN: 10195327072063, Lot Number: 22JBV692,22IBH276; wwwww. LAP CHOLE PACK, Item Number: DYNJ25891N, Case UDI/GTIN: 40193489791625, Unit UDI/GTIN: 10193489791624, Lot Number: 22JBD212; xxxxx. MINOR PACK-LF, Item Number: DYNJ26974F, Case UDI/GTIN: 40889942948865, Unit UDI/GTIN: 10889942948864, Lot Number: 22JBF049,22HBY277; yyyyy. MAJOR SET UP PACK-LF, Item Number: DYNJ26981I, Case UDI/GTIN: 40195327010035, Unit UDI/GTIN: 10195327010034, Lot Number: 22IBW001,22IBC551; zzzzz. SCC RECTAL PACK, Item Number: DYNJ27163P, Case UDI/GTIN: 40195327218677, Unit UDI/GTIN: 10195327218676, Lot Number: 22KMA170; aaaaaa. MINI LAPAROTOMY #16-RF, Item Number: DYNJ27322S, Case UDI/GTIN: 40195327140640, Unit UDI/GTIN: 10195327140649, Lot Number: 22JBH134,22IBD368; bbbbbb. LAP CHOLE PACK, Item Number: DYNJ28275N, Case UDI/GTIN: 40193489978934, Unit UDI/GTIN: 10193489978933, Lot Number: 22IME280; cccccc. LAPAROSCOPY TRAY SC-LF, Item Number: DYNJ30082C, Case UDI/GTIN: 40193489483766, Unit UDI/GTIN: 10193489483765, Lot Number: 22JMH443; dddddd. MINOR PACK, Item Number: DYNJ30425G, Case UDI/GTIN: 40195327218509, Unit UDI/GTIN: 10195327218508, Lot Number: 22JBW347,22IBE209; eeeeee. LAP CHOLE PACK, Item Number: DYNJ30544B, Case UDI/GTIN: 40889942766087, Unit UDI/GTIN: 10889942766086, Lot Number: 22JLA559,22ILA393; ffffff. SET UP PACK, Item Number: DYNJ30723D, Case UDI/GTIN: 40195327188420, Unit UDI/GTIN: 10195327188429, Lot Number: 22JMC445; gggggg. LAPAROSCOPY PACK-LF, Item Number: DYNJ30966G, Case UDI/GTIN: 40195327191468, Unit UDI/GTIN: 10195327191467, Lot Number: 22JMI229; hhhhhh. GENERAL LAPAROSCOPY PACK, Item Number: DYNJ30983I, Case UDI/GTIN: 40889942931485, Unit UDI/GTIN: 10889942931484, Lot Number: 22IME732; iiiiii. MAJOR ABDOMINAL PACK, Item Number: DYNJ30984F, Case UDI/GTIN: 40889942715788, Unit UDI/GTIN: 10889942715787, Lot Number: 22JME015,22JME014; jjjjjj. OSC MINOR PACK-LF, Item Number: DYNJ31638C, Case UDI/GTIN: 40889942465249, Unit UDI/GTIN: 10889942465248, Lot Number: 22IBB380; kkkkkk. MINOR SURGERY PACK, Item Number: DYNJ31739G, Case UDI/GTIN: 40193489994750, Unit UDI/GTIN: 10193489994759, Lot Number: 22JBX012,22IBU435; llllll. BASIC LAPAROTOMY, Item Number: DYNJ32634I, Case UDI/GTIN: 40193489728430, Unit UDI/GTIN: 10193489728439, Lot Number: 22IMB294; mmmmmm. GENERAL RECTAL PACK-LF, Item Number: DYNJ32665J, Case UDI/GTIN: 40193489962896, Unit UDI/GTIN: 10193489962895, Lot Number: 22JBX152,22JBG536,22IBU973; nnnnnn. LAP CHOLE PACK-LF, Item Number: DYNJ32935C, Case UDI/GTIN: 40888277810564, Unit UDI/GTIN: 10888277810563, Lot Number: 22JBM488; oooooo. LAP CHOLE PACK, Item Number: DYNJ33197K, Case UDI/GTIN: 40193489885072, Unit UDI/GTIN: 10193489885071, Lot Number: 22JBQ319,22IBB712; pppppp. LAPAROTOMY PK, Item Number: DYNJ34269B, Case UDI/GTIN: 40884389511795, Unit UDI/GTIN: 10884389511794, Lot Number: 22JBU912,22IBQ563,22HBQ819; qqqqqq. LAPAROSCOPIC GALLBLADDER PACK, Item Number: DYNJ34400C, Case UDI/GTIN: 40193489838696, Unit UDI/GTIN: 10193489838695, Lot Number: 22HBV127; rrrrrr. LAP CHOLE, Item Number: DYNJ34421M, Case UDI/GTIN: 40193489974783, Unit UDI/GTIN: 10193489974782, Lot Number: 22JBF707,22IBF621; ssssss. LAPAROSCOPY, Item Number: DYNJ34423K, Case UDI/GTIN: 40195327095094, Unit UDI/GTIN: 10195327095093, Lot Number: 22IBF612; tttttt. LAPAROTOMY, Item Number: DYNJ34424L, Case UDI/GTIN: 40193489969284, Unit UDI/GTIN: 10193489969283, Lot Number: 22JBO233,22IBD189,22HBP363; uuuuuu. MINOR PACK, Item Number: DYNJ34603D, Case UDI/GTIN: 40193489833660, Unit UDI/GTIN: 10193489833669, Lot Number: 22HMD399; vvvvvv. MINOR PACK, Item Number: DYNJ34874A, Case UDI/GTIN: 40888277298782, Unit UDI/GTIN: 10888277298781, Lot Number: 22IBV590,22IBG163; wwwwww. MAJOR PACK, Item Number: DYNJ35055, Case UDI/GTIN: 40884389411279, Unit UDI/GTIN: 10884389411278, Lot Number: 22JBW949; xxxxxx. MINOR PACK, Item Number: DYNJ35439D, Case UDI/GTIN: 40889942797784, Unit UDI/GTIN: 10889942797783, Lot Number: 22JBG860,22IBB083; yyyyyy. PEDIATRIC LAP PACK, Item Number: DYNJ35479F, Case UDI/GTIN: 40193489803687, Unit UDI/GTIN: 10193489803686, Lot Number: 22JMB625,22IMD854; zzzzzz. MINOR PROCEDURE PACK-LF, Item Number: DYNJ35745F, Case UDI/GTIN: 40888277782113, Unit UDI/GTIN: 10888277782112, Lot Number: 22HDB949; aaaaaaa. LAPAROSCOPY PACK, Item Number: DYNJ35816I, Case UDI/GTIN: 40889942807933, Unit UDI/GTIN: 10889942807932, Lot Number: 22JMG325; bbbbbbb. LAPAROSCOPY PACK-LF, Item Number: DYNJ36418G, Case UDI/GTIN: 40193489424394, Unit UDI/GTIN: 10193489424393, Lot Number: 22JBJ351; ccccccc. PEDIATRIC LAP PACK-LF, Item Number: DYNJ36727D, Case UDI/GTIN: 40195327148707, Unit UDI/GTIN: 10195327148706, Lot Number: 22IBN319; ddddddd. MINOR PACK-LF, Item Number: DYNJ36729D, Case UDI/GTIN: 40195327148202, Unit UDI/GTIN: 10195327148201, Lot Number: 22IBT467; eeeeeee. MINOR ABDOMINAL PROCEDURPK-LF, Item Number: DYNJ36730F, Case UDI/GTIN: 40195327148219, Unit UDI/GTIN: 10195327148218, Lot Number: 22IBL401,22IBK748; fffffff. GENERAL LAPAROSCOPY PK-LF, Item Number: DYNJ36733D, Case UDI/GTIN: 40195327148011, Unit UDI/GTIN: 10195327148010, Lot Number: 22JBE385,22IBA620; ggggggg. MINOR PACK, Item Number: DYNJ37042C, Case UDI/GTIN: 40888277747914, Unit UDI/GTIN: 10888277747913, Lot Number: 22IMG347; hhhhhhh. FHT MAJOR PACK, Item Number: DYNJ37133G, Case UDI/GTIN: 40193489932097, Unit UDI/GTIN: 10193489932096, Lot Number: 22IBR457; iiiiiii. LAP CHOLE PACK, Item Number: DYNJ37157I, Case UDI/GTIN: 40193489803397, Unit UDI/GTIN: 10193489803396, Lot Number: 22JMB632,22JMA741,22IME052; jjjjjjj. GENERAL LAPAROSCOPY PACK, Item Number: DYNJ37459D, Case UDI/GTIN: 40193489692151, Unit UDI/GTIN: 10193489692150, Lot Number: 22IBS209,22HBY279; kkkkkkk. BASIC LAPAROTOMY PACK, Item Number: DYNJ37630, Case UDI/GTIN: 40884389642055, Unit UDI/GTIN: 10884389642054, Lot Number: 22JBI658; lllllll. BASIC LAPAROTOMY PACK, Item Number: DYNJ37923B, Case UDI/GTIN: 40889942870395, Unit UDI/GTIN: 10889942870394, Lot Number: 22IBQ718,22IBB017; mmmmmmm. LAP CHOLE PACK, Item Number: DYNJ38228A, Case UDI/GTIN: 40884389784168, Unit UDI/GTIN: 10884389784167, Lot Number: 22IBV687; nnnnnnn. MINOR PACK, Item Number: DYNJ38672C, Case UDI/GTIN: 40193489583350, Unit UDI/GTIN: 10193489583359, Lot Number: 22HBV326; ooooooo. LAPAROSCOPY PACK, Item Number: DYNJ38912F, Case UDI/GTIN: 40195327157280, Unit UDI/GTIN: 10195327157289, Lot Number: 22IBC934; ppppppp. LAP BAND PACK, Item Number: DYNJ38952C, Case UDI/GTIN: 40193489838610, Unit UDI/GTIN: 10193489838619, Lot Number: 22HMC690; qqqqqqq. MINOR PROCEDURE PACK-LF, Item Number: DYNJ39022A, Case UDI/GTIN: 40195327191086, Unit UDI/GTIN: 10195327191085, Lot Number: 22JBW628,22IBP887; rrrrrrr. HERNIA PACK, Item Number: DYNJ39331B, Case UDI/GTIN: 40889942731580, Unit UDI/GTIN: 10889942731589, Lot Number: 22JBE708,22HBH194; sssssss. MINOR PACK, Item Number: DYNJ39653A, Case UDI/GTIN: 40888277549075, Unit UDI/GTIN: 10888277549074, Lot Number: 22JMC452,22JMC578; ttttttt. LAP CHOLE PACK, Item Number: DYNJ39657F, Case UDI/GTIN: 40888277770936, Unit UDI/GTIN: 10888277770935, Lot Number: 22IMB695; uuuuuuu. MAJOR LAPAROSCOPY PACK-LF, Item Number: DYNJ39740C, Case UDI/GTIN: 40193489962889, Unit UDI/GTIN: 10193489962888, Lot Number: 22IBF204,22HBL388; vvvvvvv. MINOR GEN RB-LF, Item Number: DYNJ39928C, Case UDI/GTIN: 40195327176120, Unit UDI/GTIN: 10195327176129, Lot Number: 22JMD157; wwwwwww. LAP/MULTI SERVICES L J-LF, Item Number: DYNJ39978B, Case UDI/GTIN: 40195327176137, Unit UDI/GTIN: 10195327176136, Lot Number: 22JME763,22IMG356; xxxxxxx. LAP CHOLE/HERNIA PACK, Item Number: DYNJ39987D, Case UDI/GTIN: 40195327265848, Unit UDI/GTIN: 10195327265847, Lot Number: 22JBK355; yyyyyyy. LAPAROSCOPIC PACK, Item Number: DYNJ40298C, Case UDI/GTIN: 40193489413152, Unit UDI/GTIN: 10193489413151, Lot Number: 22HBV369; zzzzzzz. HL LAPAROSCOPY PACK, Item Number: DYNJ40364A, Case UDI/GTIN: 40889942531104, Unit UDI/GTIN: 10889942531103, Lot Number: 22IBN972; aaaaaaaa. LAPAROSCOPIC PACK, Item Number: DYNJ40413D, Case UDI/GTIN: 40889942532996, Unit UDI/GTIN: 10889942532995, Lot Number: 22JBL566; bbbbbbbb. LAP CHOLE PACK, Item Number: DYNJ40462L, Case UDI/GTIN: 40195327015542, Unit UDI/GTIN: 10195327015541, Lot Number: 22JMC822,22JMD024,22HMD568; cccccccc. BASIC LAPAROTOMY PACK, Item Number: DYNJ40464L, Case UDI/GTIN: 40193489244299, Unit UDI/GTIN: 10193489244298, Lot Number: 22IME958; dddddddd. GENERAL PACK, Item Number: DYNJ40507G, Case UDI/GTIN: 40195327117499, Unit UDI/GTIN: 10195327117498, Lot Number: 22JMG009,22IMG358; eeeeeeee. LAP CHOLE PACK, Item Number: DYNJ40981F, Case UDI/GTIN: 40889942563990, Unit UDI/GTIN: 10889942563999, Lot Number: 22JBA876; ffffffff. LAP CHOLE PACK-LF, Item Number: DYNJ41052D, Case UDI/GTIN: 40195327156849, Unit UDI/GTIN: 10195327156848, Lot Number: 22JBK537; gggggggg. MAJOR PACK, Item Number: DYNJ41106F, Case UDI/GTIN: 40193489969574, Unit UDI/GTIN: 10193489969573, Lot Number: 22HBH106; hhhhhhhh. MAJOR LAPAROTOMY, Item Number: DYNJ41269B, Case UDI/GTIN: 40193489789103, Unit UDI/GTIN: 10193489789102, Lot Number: 22JMC839,22JMC840; iiiiiiii. LAP CHOLE PACK, Item Number: DYNJ41297C, Case UDI/GTIN: 40193489305297, Unit UDI/GTIN: 10193489305296, Lot Number: 22HBY585; jjjjjjjj. LAPAROTOMY BASIN, Item Number: DYNJ41354A, Case UDI/GTIN: 40888277567338, Unit UDI/GTIN: 10888277567337, Lot Number: 22HBX781; kkkkkkkk. LAPAROSCOPY PACK, Item Number: DYNJ41417J, Case UDI/GTIN: 40195327220991, Unit UDI/GTIN: 10195327220990, Lot Number: 22IBT229; llllllll. MINOR PACK, Item Number: DYNJ41418I, Case UDI/GTIN: 40195327221004, Unit UDI/GTIN: 10195327221003, Lot Number: 22IBR519,22IBN436; mmmmmmmm. LAP CHOLE PACK, Item Number: DYNJ41419I, Case UDI/GTIN: 40195327220984, Unit UDI/GTIN: 10195327220983, Lot Number: 22HDB909; nnnnnnnn. WR LAP PACK-LF, Item Number: DYNJ41573I, Case UDI/GTIN: 40195327089802, Unit UDI/GTIN: 10195327089801, Lot Number: 22JMG091; oooooooo. LAPAROTOMY PACK, Item Number: DYNJ41608, Case UDI/GTIN: 40888277010155, Unit UDI/GTIN: 10888277010154, Lot Number: 22IBB101; pppppppp. STANDARD PACK, Item Number: DYNJ41638C, Case UDI/GTIN: 40195327015009, Unit UDI/GTIN: 10195327015008, Lot Number: 22JBX190; qqqqqqqq. GENERAL ROBOTIC PACK, Item Number: DYNJ42002B, Case UDI/GTIN: 40888277918215, Unit UDI/GTIN: 10888277918214, Lot Number: 22JMG340,22HMD827,22HMD833; rrrrrrrr. BARIATRIC PACK, Item Number: DYNJ42012D, Case UDI/GTIN: 40193489691253, Unit UDI/GTIN: 10193489691252, Lot Number: 22JBP298,22IBJ095; ssssssss. LAPAROSCOPY PACK, Item Number: DYNJ42179C, Case UDI/GTIN: 40889942294481, Unit UDI/GTIN: 10889942294480, Lot Number: 22JBB010,22HBG287; tttttttt. LAP CHOLE LAPAROSCOPY PACK, Item Number: DYNJ42212B, Case UDI/GTIN: 40889942929925, Unit UDI/GTIN: 10889942929924, Lot Number: 22IBD140; uuuuuuuu. PK-GEN-LAP CHOLE, Item Number: DYNJ42385C, Case UDI/GTIN: 40195327253333, Unit UDI/GTIN: 10195327253332, Lot Number: 22JMH242; vvvvvvvv. LAP CHOLE OR PACK, Item Number: DYNJ42420B, Case UDI/GTIN: 40195327056323, Unit UDI/GTIN: 10195327056322, Lot Number: 22JBI058,22IBO179; wwwwwwww. DAVINCI PK, Item Number: DYNJ42498, Case UDI/GTIN: 40888277019776, Unit UDI/GTIN: 10888277019775, Lot Number: 22IBU442,22IBG982; xxxxxxxx. DIAGNOSTIC LAP PACK, Item Number: DYNJ42577I, Case UDI/GTIN: 40195327080311, Unit UDI/GTIN: 10195327080310, Lot Number: 22IBQ418; yyyyyyyy. DR. BROWN LAP CHOLE PLUS SETUP, Item Number: DYNJ42578F, Case UDI/GTIN: 40195327080168, Unit UDI/GTIN: 10195327080167, Lot Number: 22IBB361; zzzzzzzz. TRAUMA LAPAROTOMY PACK-LF, Item Number: DYNJ42848C, Case UDI/GTIN: 40193489880893, Unit UDI/GTIN: 10193489880892, Lot Number: 22JBU938,22IBT508,22IBA972; aaaaaaaaa. UROLOGY PERINEAL PACK-LF, Item Number: DYNJ42851B, Case UDI/GTIN: 40193489880916, Unit UDI/GTIN: 10193489880915, Lot Number: 22IBT521,22IBM131; bbbbbbbbb. LAPAROSCOPY G.B. PACK, Item Number: DYNJ42981C, Case UDI/GTIN: 40193489661706, Unit UDI/GTIN: 10193489661705, Lot Number: 22JMD833,22IMC792; ccccccccc. LAP CHOLE LOS BANOS, Item Number: DYNJ43013B, Case UDI/GTIN: 40888277292278, Unit UDI/GTIN: 10888277292277, Lot Number: 22IMF240; ddddddddd. LAP CHOLE PACK, Item Number: DYNJ43073A, Case UDI/GTIN: 40889942119364, Unit UDI/GTIN: 10889942119363, Lot Number: 22IBT760; eeeeeeeee. MINOR PACK, Item Number: DYNJ43105G, Case UDI/GTIN: 40193489311748, Unit UDI/GTIN: 10193489311747, Lot Number: 22IMH999,22IMI001; fffffffff. MINOR SET UP PACK, Item Number: DYNJ43150C, Case UDI/GTIN: 40195327227396, Unit UDI/GTIN: 10195327227395, Lot Number: 22HBY359; ggggggggg. GLENNON LAPAROSCOPIC PACK, Item Number: DYNJ43391C, Case UDI/GTIN: 40195327072088, Unit UDI/GTIN: 10195327072087, Lot Number: 22JBT636; hhhhhhhhh. GLENNON CT MINOR PACK, Item Number: DYNJ43392C, Case UDI/GTIN: 40195327067275, Unit UDI/GTIN: 10195327067274, Lot Number: 22JBS677; iiiiiiiii. LAP CHOLE PACK-LF, Item Number: DYNJ43409D, Case UDI/GTIN: 40193489936552, Unit UDI/GTIN: 10193489936551, Lot Number: 22IBH534,22HBK049; jjjjjjjjj. MAJOR PLUS PACK-LF, Item Number: DYNJ43411D, Case UDI/GTIN: 40193489901338, Unit UDI/GTIN: 10193489901337, Lot Number: 22KBA323,22IBR959,22HBQ129; kkkkkkkkk. LAPAROSCOPIC PACK, Item Number: DYNJ43701, Case UDI/GTIN: 40888277067500, Unit UDI/GTIN: 10888277067509, Lot Number: 22JME415; lllllllll. MINOR PACK, Item Number: DYNJ43784A, Case UDI/GTIN: 40889942903048, Unit UDI/GTIN: 10889942903047, Lot Number: 22JME771,22JMA711,22HMB836; mmmmmmmmm. MINOR SET UP PACK, Item Number: DYNJ43946J, Case UDI/GTIN: 40195327091898, Unit UDI/GTIN: 10195327091897, Lot Number: 22IMD719; nnnnnnnnn. MAJOR PACK, Item Number: DYNJ43947F, Case UDI/GTIN: 40195327091904, Unit UDI/GTIN: 10195327091903, Lot Number: 22IMB935,22HME443; ooooooooo. LAPAROSCOPY PACK, Item Number: DYNJ44030B, Case UDI/GTIN: 40889942483045, Unit UDI/GTIN: 10889942483044, Lot Number: 22HBT520; ppppppppp. PK, GEN-LAPAROSCOPY, Item Number: DYNJ44093B, Case UDI/GTIN: 40889942662396, Unit UDI/GTIN: 10889942662395, Lot Number: 22JBN883,22IBC424,22HBT662; qqqqqqqqq. ROBOTIC PACK, Item Number: DYNJ44095B, Case UDI/GTIN: 40195327056316, Unit UDI/GTIN: 10195327056315, Lot Number: 22IBF031,22IBG865; rrrrrrrrr. UNIVERSAL SCOPE PACK, Item Number: DYNJ45052B, Case UDI/GTIN: 40195327248742, Unit UDI/GTIN: 10195327248741, Lot Number: 22IMG044,22IMG047; sssssssss. LAPAROSCOPY GENERAL PACK, Item Number: DYNJ45083G, Case UDI/GTIN: 40195327045211, Unit UDI/GTIN: 10195327045210, Lot Number: 22JBG351,22IBN868; ttttttttt. GENERAL LAPAROSCOPY PACK, Item Number: DYNJ45263B, Case UDI/GTIN: 40193489852395, Unit UDI/GTIN: 10193489852394, Lot Number: 22HBY016,22HBY018; uuuuuuuuu. ROBOTIC PACK, Item Number: DYNJ45270B, Case UDI/GTIN: 40193489852463, Unit UDI/GTIN: 10193489852462, Lot Number: 22IBN803,22IBA816; vvvvvvvvv. LAP CHOLE, Item Number: DYNJ45333J, Case UDI/GTIN: 40195327118021, Unit UDI/GTIN:

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 16 of 38

Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY

Z-1075-2023
Recall number
Z-1075-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
48 cases (96 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ903826D, Case UDI/GTIN: 40195327177790, Unit UDI/GTIN: 10195327177799, Lot Number: 22IBR004;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 17 of 38

Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO

Z-1076-2023
Recall number
Z-1076-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
20 cases (72 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. ENDOSCOPY-LF, Item Number: DYNJ22890M, Case UDI/GTIN: 40193489766487, Unit UDI/GTIN: 10193489766486, Lot Number: 22JBM081; b. SEPTO/ENDO, Item Number: DYNJ902831D, Case UDI/GTIN: 40193489231671, Unit UDI/GTIN: 10193489231670, Lot Number: 22JBP701;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 18 of 38

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l. BREAST-HERNIA-PORT CDS-LF m. DAY SURG PLASTIC CDS n. PLASTIC SURGERY PACK o. PLASTIC PACK-LF p. PLASTIC-GENERAL SURGERY PACK q. PLASTIC PACK-LF r. ABDOMINOPLASTY/BREAST s. PLASTIC PACK t. BREAST PACK u. PLASTIC SURGERY TRAY v. BREAST AUGMENTATION PACK w. FACE PACK x. LIPOSUCTION PACK y. UNIVERSAL PLASTIC PACK z. PLASTIC PACK aa. LIPOSUCTION PACK bb. MINOR BREAST PACK cc. PLASTICS PACK-LF dd. UPPER PLASTIC PACK-LF ee. BREAST MAJOR PACK-LF ff. CAM PARTIAL MASTECTOMY PACK gg. PLASTIC PACK hh. BREAST PACK ii. BREAST RECONS COMBO PK XM-LF jj. PLASTICS PACK kk. BREAST REDUCTION PACK ll. BREAST HERNIA PK mm. T PLASTY PACK nn. ASC PLASTICS PACK oo. PLASTICS PACK-LF pp. OCULOPLASTIC PICK PACK qq. PLASTIC SURGERY LF PACK rr. PLASTIC PACK ss. OCULAR PLASTIC PACK tt. CHEST BREAST PACK uu. BREAST PACK vv. MAJOR PLASTIC PACK ww. FACIAL PLASTICS PACK xx. PLASTIC PACK yy. BREAST PACK zz. CHEST/BREAST PACK aaa. BREAST PACK bbb. BREAST PACK LJ-LF ccc. SCRIPPS SW PLASTIC PACK ddd. BREAST PACK eee. BREAST PACK fff. PLASTIC SURGERY U-BAR PACK ggg. PHOENIXVILLE BREAST PACK hhh. LAB PLASTIC PACK #DF2 iii. PLASTIC PACK jjj. GENERAL PLASTIC PACK kkk. CHEST/BREAST lll. MAJOR PLASTIC PACK mmm. MAJOR BREAST PACK nnn. BREAST ABDOMINOPLASTY PACK ooo. DR HOLCOMB FACIAL PACK ppp. MAJOR PLASTIC BREAST PACK qqq. DIAZ PACK rrr. BREAST PACK sss. BREAST PACK ttt. CHEST PACK uuu. PLASTIC FACIAL PACK vvv. FACIAL PLASTICS PACK www. BLEPHAROPLASTY PACK xxx. BREAST PACK - MOISES yyy. PLASTIC PACK zzz. PLASTIC PACK aaaa. BREAST AUGMENTATION PACK bbbb. CHEST/BREAST cccc. BREAST PACK dddd. PLASTIC PACK eeee. PLASTICS PACK ffff. PLASTIC PACK gggg. CHEST BREAST PACK hhhh. PLASTIC PACK iiii. CAROLINA FACIAL PLASTIC PACK jjjj. BREAST PACK kkkk. CHEST BREAST PACK llll. BREAST DBL PROCED SUPPLEMENT mmmm. BREAST PACK nnnn. PLASTIC PACK oooo. PLASTICS PACK pppp. ESC PLASTICS PACK qqqq. FACE LIFT PACK rrrr. CHEST BREAST ssss. BREAST PACK tttt. MINOR PLASTIC PACK uuuu. #2 FACIAL PLASTY PACK vvvv. BBL PACK wwww. BASIC PACK xxxx. BREAST PACK yyyy. BREAST AUGMENTATION PACK zzzz. BREAST PACK aaaaa. MAJOR BREAST OR UNIVERSAL bbbbb. CHEST/BREAST-LF ccccc. CUSTOM PLASTIC PACK ddddd. CHEST/BREAST PACK eeeee. PLASTIC GENERAL PACK fffff. SPECIALTY FACIAL PLASTICS PACK ggggg. OCCULOPLASTICS PACK hhhhh. BREAST PACK iiiii. LIPOSUCTION PACK jjjjj. BREAST PACK kkkkk. PLASTICS PACK lllll. BREAST PACK mmmmm. BREAST REDUCTION PACK nnnnn. BREAST AUGMENTATION PACK ooooo. FACE/RHINOPLASTY PACK ppppp. BREAST PACK qqqqq. TUMMY TUCK PACK rrrrr. BREAST PACK sssss. PLASTICS PACK ttttt. BREAST/ABDOMINAL PACK uuuuu. PLASTIC PACK vvvvv. BREAST PACK wwwww. RECONSTRUCTION PACK xxxxx. PLASTIC PACK yyyyy. PLASTICS PACK zzzzz. PLASTICS PACK aaaaaa. GENERAL PLASTIC-LF bbbbbb. PLASTIC UNIVERSAL cccccc. BREAST HA-LF dddddd. BREAST eeeeee. PLASTIC ffffff. BREAST gggggg. MAJOR BREAST hhhhhh. CHEST/BREAST-MRMCASU iiiiii. BREAST RECONSTRUCTION PACK jjjjjj. CHEST/BREAST kkkkkk. BREAST PACK llllll. BREAST BIOPSY/MASTECTOMY mmmmmm. CHEST/BREAST-LF

Z-1077-2023
Recall number
Z-1077-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
6,420 cases (15,009 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. BREAST AUGMENTATION, Item Number: CDS982254L, Case UDI/GTIN: 40195327084791, Unit UDI/GTIN: 10195327084790, Lot Number: 22JBU069,22IBN271; b. BREAST REDUCTION CDS, Item Number: CDS982255I, Case UDI/GTIN: 40195327084807, Unit UDI/GTIN: 10195327084806, Lot Number: 22JBB306; c. CUH ABDOMINOPLASTY CDS, Item Number: CDS983176I, Case UDI/GTIN: 40193489767477, Unit UDI/GTIN: 10193489767476, Lot Number: 22JBJ560,22JBD705; d. ACH PLASTICS BREAST-LF, Item Number: CDS983639J, Case UDI/GTIN: 40195327228140, Unit UDI/GTIN: 10195327228149, Lot Number: 22IBF012,22IBF004; e. NE BREAST RECON CDS, Item Number: CDS983660G, Case UDI/GTIN: 40193489952675, Unit UDI/GTIN: 10193489952674, Lot Number: 22IBR079; f. PLASTIC SURGERY CDS, Item Number: CDS983880C, Case UDI/GTIN: 40193489435963, Unit UDI/GTIN: 10193489435962, Lot Number: 22JBT961; g. MINOR PLASTIC CDS, Item Number: CDS984174F, Case UDI/GTIN: 40195327084777, Unit UDI/GTIN: 10195327084776, Lot Number: 22JBM928,22JBM929; h. GROTH BREAST CDS, Item Number: CDS984202U, Case UDI/GTIN: 40195327146307, Unit UDI/GTIN: 10195327146306, Lot Number: 22JBA856,22IBC582,22IBD063; i. BREAST ABD, Item Number: CDS984267J, Case UDI/GTIN: 40193489288873, Unit UDI/GTIN: 10193489288872, Lot Number: 22IBF074; j. MINOR/U-BAR CDS-LF, Item Number: CDS984539J, Case UDI/GTIN: 40193489903189, Unit UDI/GTIN: 10193489903188, Lot Number: 22JDB904; k. PLASTIC BREAST CDS-LF, Item Number: CDS984851K, Case UDI/GTIN: 40195327195398, Unit UDI/GTIN: 10195327195397, Lot Number: 22JDB505; l. BREAST-HERNIA-PORT CDS-LF, Item Number: CDS984853I, Case UDI/GTIN: 40195327071760, Unit UDI/GTIN: 10195327071769, Lot Number: 22JDA801; m. DAY SURG PLASTIC CDS, Item Number: CDS984993O, Case UDI/GTIN: 40195327175765, Unit UDI/GTIN: 10195327175764, Lot Number: 22JBJ441,22JBE422; n. PLASTIC SURGERY PACK, Item Number: DYNJ04750G, Case UDI/GTIN: 40193489511957, Unit UDI/GTIN: 10193489511956, Lot Number: 22JMB163; o. PLASTIC PACK-LF, Item Number: DYNJ0781642R, Case UDI/GTIN: 40193489919173, Unit UDI/GTIN: 10193489919172, Lot Number: 22JMF191,22HMD493; p. PLASTIC-GENERAL SURGERY PACK, Item Number: DYNJ09866U, Case UDI/GTIN: 40193489259590, Unit UDI/GTIN: 10193489259599, Lot Number: 22JMG311; q. PLASTIC PACK-LF, Item Number: DYNJ20497K, Case UDI/GTIN: 40195327024599, Unit UDI/GTIN: 10195327024598, Lot Number: 22JLB117,22ILA021; r. ABDOMINOPLASTY/BREAST, Item Number: DYNJ21842I, Case UDI/GTIN: 40888277256508, Unit UDI/GTIN: 10888277256507, Lot Number: 22IMH619; s. PLASTIC PACK, Item Number: DYNJ26438G, Case UDI/GTIN: 40888277785350, Unit UDI/GTIN: 10888277785359, Lot Number: 22JBI434,22HBZ290; t. BREAST PACK, Item Number: DYNJ28206K, Case UDI/GTIN: 40195327106943, Unit UDI/GTIN: 10195327106942, Lot Number: 22JBU625; u. PLASTIC SURGERY TRAY, Item Number: DYNJ30115G, Case UDI/GTIN: 40889942303862, Unit UDI/GTIN: 10889942303861, Lot Number: 22HBV982; v. BREAST AUGMENTATION PACK, Item Number: DYNJ33977L, Case UDI/GTIN: 40193489859936, Unit UDI/GTIN: 10193489859935, Lot Number: 22JBO157; w. FACE PACK, Item Number: DYNJ34217A, Case UDI/GTIN: 40888277093097, Unit UDI/GTIN: 10888277093096, Lot Number: 22KBA576; x. LIPOSUCTION PACK, Item Number: DYNJ34219B, Case UDI/GTIN: 40889942274834, Unit UDI/GTIN: 10889942274833, Lot Number: 22JBE559; y. UNIVERSAL PLASTIC PACK, Item Number: DYNJ34914B, Case UDI/GTIN: 40888277866486, Unit UDI/GTIN: 10888277866485, Lot Number: 22IBG525; z. PLASTIC PACK, Item Number: DYNJ35262A, Case UDI/GTIN: 40193489903431, Unit UDI/GTIN: 10193489903430, Lot Number: 22HBW347; aa. LIPOSUCTION PACK, Item Number: DYNJ35551A, Case UDI/GTIN: 40195327097876, Unit UDI/GTIN: 10195327097875, Lot Number: 22JBK100,22IBJ806; bb. MINOR BREAST PACK, Item Number: DYNJ35553C, Case UDI/GTIN: 40195327097852, Unit UDI/GTIN: 10195327097851, Lot Number: 22HBY241; cc. PLASTICS PACK-LF, Item Number: DYNJ36107J, Case UDI/GTIN: 40195327080274, Unit UDI/GTIN: 10195327080273, Lot Number: 22JME255; dd. UPPER PLASTIC PACK-LF, Item Number: DYNJ36718D, Case UDI/GTIN: 40195327148769, Unit UDI/GTIN: 10195327148768, Lot Number: 22JBL537,22IBG025; ee. BREAST MAJOR PACK-LF, Item Number: DYNJ36734G, Case UDI/GTIN: 40195327147410, Unit UDI/GTIN: 10195327147419, Lot Number: 22HBQ666; ff. CAM PARTIAL MASTECTOMY PACK, Item Number: DYNJ37628C, Case UDI/GTIN: 40889942461050, Unit UDI/GTIN: 10889942461059, Lot Number: 22IBU399; gg. PLASTIC PACK, Item Number: DYNJ38189D, Case UDI/GTIN: 40193489468343, Unit UDI/GTIN: 10193489468342, Lot Number: 22IBO436; hh. BREAST PACK, Item Number: DYNJ39195F, Case UDI/GTIN: 40193489986908, Unit UDI/GTIN: 10193489986907, Lot Number: 22IBO383; ii. BREAST RECONS COMBO PK XM-LF, Item Number: DYNJ39833C, Case UDI/GTIN: 40195327191376, Unit UDI/GTIN: 10195327191375, Lot Number: 22FMI348; jj. PLASTICS PACK, Item Number: DYNJ40140G, Case UDI/GTIN: 40193489265867, Unit UDI/GTIN: 10193489265866, Lot Number: 22IBH452; kk. BREAST REDUCTION PACK, Item Number: DYNJ41002, Case UDI/GTIN: 40884389895413, Unit UDI/GTIN: 10884389895412, Lot Number: 22IBS571; ll. BREAST HERNIA PK, Item Number: DYNJ41083D, Case UDI/GTIN: 40889942233459, Unit UDI/GTIN: 10889942233458, Lot Number: 22JBF548; mm. T PLASTY PACK, Item Number: DYNJ41985C, Case UDI/GTIN: 40193489258173, Unit UDI/GTIN: 10193489258172, Lot Number: 22JDC078,22IDA602; nn. ASC PLASTICS PACK, Item Number: DYNJ42011C, Case UDI/GTIN: 40888277938299, Unit UDI/GTIN: 10888277938298, Lot Number: 22JBG927,22IBB058; oo. PLASTICS PACK-LF, Item Number: DYNJ43418C, Case UDI/GTIN: 40193489450867, Unit UDI/GTIN: 10193489450866, Lot Number: 22IBP842; pp. OCULOPLASTIC PICK PACK, Item Number: DYNJ43914B, Case UDI/GTIN: 40889942437079, Unit UDI/GTIN: 10889942437078, Lot Number: 22JBE764; qq. PLASTIC SURGERY LF PACK, Item Number: DYNJ43942, Case UDI/GTIN: 40888277075468, Unit UDI/GTIN: 10888277075467, Lot Number: 22HBX782,22HBX206; rr. PLASTIC PACK, Item Number: DYNJ44099A, Case UDI/GTIN: 40889942490142, Unit UDI/GTIN: 10889942490141, Lot Number: 22JMH703,22JMA840,22HMF001; ss. OCULAR PLASTIC PACK, Item Number: DYNJ45041B, Case UDI/GTIN: 40888277807434, Unit UDI/GTIN: 10888277807433, Lot Number: 22JBE786; tt. CHEST BREAST PACK, Item Number: DYNJ46084, Case UDI/GTIN: 40888277221001, Unit UDI/GTIN: 10888277221000, Lot Number: 22HLB316; uu. BREAST PACK, Item Number: DYNJ46229, Case UDI/GTIN: 40888277228345, Unit UDI/GTIN: 10888277228344, Lot Number: 22JBW530,22IBT433; vv. MAJOR PLASTIC PACK, Item Number: DYNJ46515K, Case UDI/GTIN: 40195327008216, Unit UDI/GTIN: 10195327008215, Lot Number: 22IDA743,22IDA715,22HDB738; ww. FACIAL PLASTICS PACK, Item Number: DYNJ46537J, Case UDI/GTIN: 40193489991520, Unit UDI/GTIN: 10193489991529, Lot Number: 22IBM221; xx. PLASTIC PACK, Item Number: DYNJ47294, Case UDI/GTIN: 40888277298362, Unit UDI/GTIN: 10888277298361, Lot Number: 22JBV790,22HBO967; yy. BREAST PACK, Item Number: DYNJ48160B, Case UDI/GTIN: 40888277877611, Unit UDI/GTIN: 10888277877610, Lot Number: 22HBR197,22HBL573; zz. CHEST/BREAST PACK, Item Number: DYNJ48606, Case UDI/GTIN: 40888277915399, Unit UDI/GTIN: 10888277915398, Lot Number: 22IBO455; aaa. BREAST PACK, Item Number: DYNJ48646B, Case UDI/GTIN: 40195327225071, Unit UDI/GTIN: 10195327225070, Lot Number: 22JMG350; bbb. BREAST PACK LJ-LF, Item Number: DYNJ49642B, Case UDI/GTIN: 40195327191390, Unit UDI/GTIN: 10195327191399, Lot Number: 22HMG224; ccc. SCRIPPS SW PLASTIC PACK, Item Number: DYNJ49652C, Case UDI/GTIN: 40195327191338, Unit UDI/GTIN: 10195327191337, Lot Number: 22JME793,22HMI024,22HMH476; ddd. BREAST PACK, Item Number: DYNJ50369A, Case UDI/GTIN: 40889942442035, Unit UDI/GTIN: 10889942442034, Lot Number: 22IBH202; eee. BREAST PACK, Item Number: DYNJ50562A, Case UDI/GTIN: 40889942716525, Unit UDI/GTIN: 10889942716524, Lot Number: 22JBW809,22JBK542,22IBB103; fff. PLASTIC SURGERY U-BAR PACK, Item Number: DYNJ50810D, Case UDI/GTIN: 40889942675242, Unit UDI/GTIN: 10889942675241, Lot Number: 22JBW438,22HBV062; ggg. PHOENIXVILLE BREAST PACK, Item Number: DYNJ51358B, Case UDI/GTIN: 40193489745208, Unit UDI/GTIN: 10193489745207, Lot Number: 22IBP954,22HBH541; hhh. LAB PLASTIC PACK #DF2, Item Number: DYNJ51648B, Case UDI/GTIN: 40888277783776, Unit UDI/GTIN: 10888277783775, Lot Number: 22JBP932; iii. PLASTIC PACK, Item Number: DYNJ51833A, Case UDI/GTIN: 40888277777256, Unit UDI/GTIN: 10888277777255, Lot Number: 22IBU484,22HBS916; jjj. GENERAL PLASTIC PACK, Item Number: DYNJ52004F, Case UDI/GTIN: 40193489926744, Unit UDI/GTIN: 10193489926743, Lot Number: 22JBW381,22JBI156,22HBO273; kkk. CHEST/BREAST, Item Number: DYNJ52495A, Case UDI/GTIN: 40195327132065, Unit UDI/GTIN: 10195327132064, Lot Number: 22JBV763,22IBJ865; lll. MAJOR PLASTIC PACK, Item Number: DYNJ52759F, Case UDI/GTIN: 40193489929486, Unit UDI/GTIN: 10193489929485, Lot Number: 22JBW704; mmm. MAJOR BREAST PACK, Item Number: DYNJ52781C, Case UDI/GTIN: 40193489568630, Unit UDI/GTIN: 10193489568639, Lot Number: 22IBN257; nnn. BREAST ABDOMINOPLASTY PACK, Item Number: DYNJ54092G, Case UDI/GTIN: 40195327250868, Unit UDI/GTIN: 10195327250867, Lot Number: 22JME425; ooo. DR HOLCOMB FACIAL PACK, Item Number: DYNJ54488A, Case UDI/GTIN: 40193489587860, Unit UDI/GTIN: 10193489587869, Lot Number: 22JBW776; ppp. MAJOR PLASTIC BREAST PACK, Item Number: DYNJ54833B, Case UDI/GTIN: 40195327133727, Unit UDI/GTIN: 10195327133726, Lot Number: 22JME810; qqq. DIAZ PACK, Item Number: DYNJ55107F, Case UDI/GTIN: 40195327085651, Unit UDI/GTIN: 10195327085650, Lot Number: 22IBO652; rrr. BREAST PACK, Item Number: DYNJ55710A, Case UDI/GTIN: 40193489937337, Unit UDI/GTIN: 10193489937336, Lot Number: 22IMD755; sss. BREAST PACK, Item Number: DYNJ56344B, Case UDI/GTIN: 40889942612322, Unit UDI/GTIN: 10889942612321, Lot Number: 22ILA563,22ILA180; ttt. CHEST PACK, Item Number: DYNJ56368, Case UDI/GTIN: 40889942638179, Unit UDI/GTIN: 10889942638178, Lot Number: 22JDA291,22IDB838; uuu. PLASTIC FACIAL PACK, Item Number: DYNJ56404B, Case UDI/GTIN: 40195327124633, Unit UDI/GTIN: 10195327124632, Lot Number: 22IBL239; vvv. FACIAL PLASTICS PACK, Item Number: DYNJ56768A, Case UDI/GTIN: 40193489648479, Unit UDI/GTIN: 10193489648478, Lot Number: 22HBH151; www. BLEPHAROPLASTY PACK, Item Number: DYNJ56859C, Case UDI/GTIN: 40193489224925, Unit UDI/GTIN: 10193489224924, Lot Number: 22IMI006; xxx. BREAST PACK - MOISES, Item Number: DYNJ57118A, Case UDI/GTIN: 40193489623667, Unit UDI/GTIN: 10193489623666, Lot Number: 22HBY162; yyy. PLASTIC PACK, Item Number: DYNJ57895, Case UDI/GTIN: 40889942790372, Unit UDI/GTIN: 10889942790371, Lot Number: 22JBN175; zzz. PLASTIC PACK, Item Number: DYNJ59445B, Case UDI/GTIN: 40193489220071, Unit UDI/GTIN: 10193489220070, Lot Number: 22IBP590; aaaa. BREAST AUGMENTATION PACK, Item Number: DYNJ59455B, Case UDI/GTIN: 40193489362078, Unit UDI/GTIN: 10193489362077, Lot Number: 22JBF745; bbbb. CHEST/BREAST, Item Number: DYNJ59712B, Case UDI/GTIN: 40193489849357, Unit UDI/GTIN: 10193489849356, Lot Number: 22JBX989,22IBA042; cccc. BREAST PACK, Item Number: DYNJ60026, Case UDI/GTIN: 40888277792402, Unit UDI/GTIN: 10888277792401, Lot Number: 22JBS904; dddd. PLASTIC PACK, Item Number: DYNJ61755B, Case UDI/GTIN: 40195327149551, Unit UDI/GTIN: 10195327149550, Lot Number: 22JMD332,22HMF130; eeee. PLASTICS PACK, Item Number: DYNJ61790B, Case UDI/GTIN: 40193489316125, Unit UDI/GTIN: 10193489316124, Lot Number: 22JBN158,22IBA388,22HBL885; ffff. PLASTIC PACK, Item Number: DYNJ62042, Case UDI/GTIN: 40193489619257, Unit UDI/GTIN: 10193489619256, Lot Number: 22JME417; gggg. CHEST BREAST PACK, Item Number: DYNJ62098C, Case UDI/GTIN: 40193489480017, Unit UDI/GTIN: 10193489480016, Lot Number: 22HME923; hhhh. PLASTIC PACK, Item Number: DYNJ63117, Case UDI/GTIN: 40193489713801, Unit UDI/GTIN: 10193489713800, Lot Number: 22JBP063,22IBJ716; iiii. CAROLINA FACIAL PLASTIC PACK, Item Number: DYNJ63180, Case UDI/GTIN: 40193489723060, Unit UDI/GTIN: 10193489723069, Lot Number: 22JBL015; jjjj. BREAST PACK, Item Number: DYNJ63217, Case UDI/GTIN: 40193489729123, Unit UDI/GTIN: 10193489729122, Lot Number: 22IBA404; kkkk. CHEST BREAST PACK, Item Number: DYNJ63290B, Case UDI/GTIN: 40195327196272, Unit UDI/GTIN: 10195327196271, Lot Number: 22HBK714; llll. BREAST DBL PROCED SUPPLEMENT, Item Number: DYNJ63893, Case UDI/GTIN: 40193489771566, Unit UDI/GTIN: 10193489771565, Lot Number: 22JBI166; mmmm. BREAST PACK, Item Number: DYNJ64179, Case UDI/GTIN: 40193489792653, Unit UDI/GTIN: 10193489792652, Lot Number: 22JBP470,22JBB019,22IBG074,22HBP241; nnnn. PLASTIC PACK, Item Number: DYNJ64308B, Case UDI/GTIN: 40195327125029, Unit UDI/GTIN: 10195327125028, Lot Number: 22GDA095,22CDB784; oooo. PLASTICS PACK, Item Number: DYNJ64418, Case UDI/GTIN: 40193489813068, Unit UDI/GTIN: 10193489813067, Lot Number: 22JBI248; pppp. ESC PLASTICS PACK, Item Number: DYNJ64635B, Case UDI/GTIN: 40195327045754, Unit UDI/GTIN: 10195327045753, Lot Number: 22IBR794; qqqq. FACE LIFT PACK, Item Number: DYNJ64670B, Case UDI/GTIN: 40193489484404, Unit UDI/GTIN: 10193489484403, Lot Number: 22IBA242,22HBM677; rrrr. CHEST BREAST, Item Number: DYNJ64736A, Case UDI/GTIN: 40193489456012, Unit UDI/GTIN: 10193489456011, Lot Number: 22JDA326; ssss. BREAST PACK, Item Number: DYNJ64810A, Case UDI/GTIN: 40193489904988, Unit UDI/GTIN: 10193489904987, Lot Number: 22JMA873; tttt. MINOR PLASTIC PACK, Item Number: DYNJ64947, Case UDI/GTIN: 40193489233613, Unit UDI/GTIN: 10193489233612, Lot Number: 22HLA405; uuuu. #2 FACIAL PLASTY PACK, Item Number: DYNJ64963, Case UDI/GTIN: 40193489234894, Unit UDI/GTIN: 10193489234893, Lot Number: 22IBB122; vvvv. BBL PACK, Item Number: DYNJ65169D, Case UDI/GTIN: 40193489963114, Unit UDI/GTIN: 10193489963113, Lot Number: 22IBI908,22HBP707; wwww. BASIC PACK, Item Number: DYNJ65328A, Case UDI/GTIN: 40193489954853, Unit UDI/GTIN: 10193489954852, Lot Number: 22JBC639; xxxx. BREAST PACK, Item Number: DYNJ65333A, Case UDI/GTIN: 40193489954860, Unit UDI/GTIN: 10193489954869, Lot Number: 22JMA988; yyyy. BREAST AUGMENTATION PACK, Item Number: DYNJ66015, Case UDI/GTIN: 40193489314947, Unit UDI/GTIN: 10193489314946, Lot Number: 22KLA065,22HLA980; zzzz. BREAST PACK, Item Number: DYNJ66673B, Case UDI/GTIN: 40193489898362, Unit UDI/GTIN: 10193489898361, Lot Number: 22JBK545; aaaaa. MAJOR BREAST OR UNIVERSAL, Item Number: DYNJ67498A, Case UDI/GTIN: 40195327039685, Unit UDI/GTIN: 10195327039684, Lot Number: 22HBS121; bbbbb. CHEST/BREAST-LF, Item Number: DYNJ67852B, Case UDI/GTIN: 40195327177516, Unit UDI/GTIN: 10195327177515, Lot Number: 22HBW474; ccccc. CUSTOM PLASTIC PACK, Item Number: DYNJ68062, Case UDI/GTIN: 40193489474580, Unit UDI/GTIN: 10193489474589, Lot Number: 22JBL801; ddddd. CHEST/BREAST PACK, Item Number: DYNJ68337, Case UDI/GTIN: 40193489437479, Unit UDI/GTIN: 10193489437478, Lot Number: 22JBF706; eeeee. PLASTIC GENERAL PACK, Item Number: DYNJ68467, Case UDI/GTIN: 40193489464581, Unit UDI/GTIN: 10193489464580, Lot Number: 22IBK005; fffff. SPECIALTY FACIAL PLASTICS PACK, Item Number: DYNJ68844A, Case UDI/GTIN: 40195327216505, Unit UDI/GTIN: 10195327216504, Lot Number: 22HMF458; ggggg. OCCULOPLASTICS PACK, Item Number: DYNJ69084B, Case UDI/GTIN: 40195327110353, Unit UDI/GTIN: 10195327110352, Lot Number: 22JBM523; hhhhh. BREAST PACK, Item Number: DYNJ69319, Case UDI/GTIN: 40193489931120, Unit UDI/GTIN: 10193489931129, Lot Number: 22JBW897,22JBJ494; iiiii. LIPOSUCTION PACK, Item Number: DYNJ69484A, Case UDI/GTIN: 40195327001996, Unit UDI/GTIN: 10195327001995, Lot Number: 22IBO417; jjjjj. BREAST PACK, Item Number: DYNJ69656A, Case UDI/GTIN: 40195327179770, Unit UDI/GTIN: 10195327179779, Lot Number: 22HMD690; kkkkk. PLASTICS PACK, Item Number: DYNJ80020, Case UDI/GTIN: 40195327006427, Unit UDI/GTIN: 10195327006426, Lot Number: 22HBW524; lllll. BREAST PACK, Item Number: DYNJ80116, Case UDI/GTIN: 40195327008834, Unit UDI/GTIN: 10195327008833, Lot Number: 22HBM836; mmmmm. BREAST REDUCTION PACK, Item Number: DYNJ80336B, Case UDI/GTIN: 40195327163342, Unit UDI/GTIN: 10195327163341, Lot Number: 22IBK852; nnnnn. BREAST AUGMENTATION PACK, Item Number: DYNJ80337A, Case UDI/GTIN: 40195327106424, Unit UDI/GTIN: 10195327106423, Lot Number: 22CBG865; ooooo. FACE/RHINOPLASTY PACK, Item Number: DYNJ80343B, Case UDI/GTIN: 40195327134892, Unit UDI/GTIN: 10195327134891, Lot Number: 22IBA953; ppppp. BREAST PACK, Item Number: DYNJ80344B, Case UDI/GTIN: 40195327134908, Unit UDI/GTIN: 10195327134907, Lot Number: 22IBL114,22IBA954; qqqqq. TUMMY TUCK PACK, Item Number: DYNJ80723, Case UDI/GTIN: 40195327070930, Unit UDI/GTIN: 10195327070939, Lot Number: 22JMA679; rrrrr. BREAST PACK, Item Number: DYNJ81403, Case UDI/GTIN: 40195327116751, Unit UDI/GTIN: 10195327116750, Lot Number: 22IBJ907,22GBM174,22EBF641; sssss. PLASTICS PACK, Item Number: DYNJ81692, Case UDI/GTIN: 40195327135233, Unit UDI/GTIN: 10195327135232, Lot Number: 22IBR325; ttttt. BREAST/ABDOMINAL PACK, Item Number: DYNJ81978, Case UDI/GTIN: 40195327158621, Unit UDI/GTIN: 10195327158620, Lot Number: 22GBX424; uuuuu. PLASTIC PACK, Item Number: DYNJ82495, Case UDI/GTIN: 40195327197514, Unit UDI/GTIN: 10195327197513, Lot Number: 22HBJ950; vvvvv. BREAST PACK, Item Number: DYNJ82522, Case UDI/GTIN: 40195327198382, Unit UDI/GTIN: 10195327198381, Lot Number: 22HBL506; wwwww. RECONSTRUCTION PACK, Item Number: DYNJ82532, Case UDI/GTIN: 40195327198481, Unit UDI/GTIN: 10195327198480, Lot Number: 22HBR206; xxxxx. PLASTIC PACK, Item Number: DYNJ82571, Case UDI/GTIN: 40195327198078, Unit UDI/GTIN: 10195327198077, Lot Number: 22HBP287; yyyyy. PLASTICS PACK, Item Number: DYNJ82648, Case UDI/GTIN: 40195327199471, Unit UDI/GTIN: 10195327199470, Lot Number: 22HBL972,22HBH559; zzzzz. PLASTICS PACK, Item Number: DYNJ83112, Case UDI/GTIN: 40195327233298, Unit UDI/GTIN: 10195327233297, Lot Number: 22HBP990; aaaaaa. GENERAL PLASTIC-LF, Item Number: DYNJ901738M, Case UDI/GTIN: 40195327153121, Unit UDI/GTIN: 10195327153120, Lot Number: 22IDB808; bbbbbb. PLASTIC UNIVERSAL, Item Number: DYNJ901792I, Case UDI/GTIN: 40193489716505, Unit UDI/GTIN: 10193489716504, Lot Number: 22IBD811,22IBD810; cccccc. BREAST HA-LF, Item Number: DYNJ902790C, Case UDI/GTIN: 40193489438483, Unit UDI/GTIN: 10193489438482, Lot Number: 22JBO945,22JBN993; dddddd. BREAST, Item Number: DYNJ902829A, Case UDI/GTIN: 40193489640831, Unit UDI/GTIN: 10193489640830, Lot Number: 22JBH277; eeeeee. PLASTIC, Item Number: DYNJ903330N, Case UDI/GTIN: 40195327236503, Unit UDI/GTIN: 10195327236502, Lot Number: 22KBC314,22JBR445,22JBA441; ffffff. BREAST, Item Number: DYNJ904598B, Case UDI/GTIN: 40889942946359, Unit UDI/GTIN: 10889942946358, Lot Number: 22KBC968,22KBC969; gggggg. MAJOR BREAST, Item Number: DYNJ905004B, Case UDI/GTIN: 40193489782586, Unit UDI/GTIN: 10193489782585, Lot Number: 22IBC407,22IBA668,22IBA065; hhhhhh. CHEST/BREAST-MRMCASU, Item Number: DYNJ907744C, Case UDI/GTIN: 40195327181032, Unit UDI/GTIN: 10195327181031, Lot Number: 22JBP014; iiiiii. BREAST RECONSTRUCTION PACK, Item Number: DYNJ907791B, Case UDI/GTIN: 40195327185238, Unit UDI/GTIN: 10195327185237, Lot Number: 22KBE789,22KBB846; jjjjjj. CHEST/BREAST, Item Number: DYNJ908433B, Case UDI/GTIN: 40195327255962, Unit UDI/GTIN: 10195327255961, Lot Number: 22JBL359,22JBM145; kkkkkk. BREAST PACK, Item Number: DYNJ908729, Case UDI/GTIN: 40195327159222, Unit UDI/GTIN: 10195327159221, Lot Number: 22JBH434; llllll. BREAST BIOPSY/MASTECTOMY, Item Number: DYNJ908839, Case UDI/GTIN: 40195327184439, Unit UDI/GTIN: 10195327184438, Lot Number: 22HBT534; mmmmmm. CHEST/BREAST-LF, Item Number: DYNJS0201, Case UDI/GTIN: 40080196813095, Unit UDI/GTIN: 10080196813094, Lot Number: 22IBU891,22HBX417

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 19 of 38

Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN

Z-1078-2023
Recall number
Z-1078-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
2.542 cases (6,739 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. ST. ANNE'S MAJOR BASIN SET UP, Item Number: DYNJ24628M, Case UDI/GTIN: 40195327109135, Unit UDI/GTIN: 10195327109134, Lot Number: 22JLA323,22ILA590; b. SINGLE BASIN SET, Item Number: DYNJ35592K, Case UDI/GTIN: 40195327110827, Unit UDI/GTIN: 10195327110826, Lot Number: 22JBW819,22IBK206; c. DOUBLE BASIN SET, Item Number: DYNJ35596G, Case UDI/GTIN: 40195327110810, Unit UDI/GTIN: 10195327110819, Lot Number: 22JBH675,22HBY465; d. LAPAROTOMY BASIN, Item Number: DYNJ41354B, Case UDI/GTIN: 40195327246311, Unit UDI/GTIN: 10195327246310, Lot Number: 22JBE052; e. ORTHOPEDIC CUSTOM BASIN SET, Item Number: DYNJ47991J, Case UDI/GTIN: 40195327230600, Unit UDI/GTIN: 10195327230609, Lot Number: 22JBX225,22JBH710,22HBW917,22HBV171; f. OISC BASIN TRAY, Item Number: DYNJ48354I, Case UDI/GTIN: 40195327154302, Unit UDI/GTIN: 10195327154301, Lot Number: 22IMF862; g. BASIN PACK, Item Number: DYNJ50123D, Case UDI/GTIN: 40195327201990, Unit UDI/GTIN: 10195327201999, Lot Number: 22HBU014; h. BASIN SET, Item Number: DYNJ50906F, Case UDI/GTIN: 40195327140145, Unit UDI/GTIN: 10195327140144, Lot Number: 22JMB641,22HMD087; i. SURGI START PACK, Item Number: DYNJ52541D, Case UDI/GTIN: 40195327164509, Unit UDI/GTIN: 10195327164508, Lot Number: 22JBH137; j. PK, GEN-SET UP - MIDWEST, Item Number: DYNJ57608B, Case UDI/GTIN: 40195327253296, Unit UDI/GTIN: 10195327253295, Lot Number: 22JMB780; k. SINGLE BASIN PACK-LF, Item Number: DYNJ58389D, Case UDI/GTIN: 40195327144198, Unit UDI/GTIN: 10195327144197, Lot Number: 22GBW998; l. AGHM MINOR SINGLE PACK, Item Number: DYNJ62766B, Case UDI/GTIN: 40195327116775, Unit UDI/GTIN: 10195327116774, Lot Number: 22JMC641,22HMD203; m. MINOR PACK, Item Number: DYNJ63961B, Case UDI/GTIN: 40195327146970, Unit UDI/GTIN: 10195327146979, Lot Number: 22IDA519; n. SINGLE BASIN PACK, Item Number: DYNJ66012A, Case UDI/GTIN: 40195327221455, Unit UDI/GTIN: 10195327221454, Lot Number: 22JLA612,22ILA886,22HLA208; o. MAJOR BASIN PACK, Item Number: DYNJ69406A, Case UDI/GTIN: 40195327112333, Unit UDI/GTIN: 10195327112332, Lot Number: 22JMH995,22JMA882; p. BASIC SET UP-LF, Item Number: DYNJ81646, Case UDI/GTIN: 40195327130269, Unit UDI/GTIN: 10195327130268, Lot Number: 22IBH244; q. BASIC SET-UP-LF, Item Number: DYNJ82390, Case UDI/GTIN: 40195327189540, Unit UDI/GTIN: 10195327189549, Lot Number: 22JBV631,22IBC646; r. BASIN PACK, Item Number: DYNJ82969, Case UDI/GTIN: 40195327218325, Unit UDI/GTIN: 10195327218324, Lot Number: 22JBN923; s. MINOR BASIN, Item Number: DYNJ907808B, Case UDI/GTIN: 40195327244430, Unit UDI/GTIN: 10195327244439, Lot Number: 22JBU478,22JBA257,22IBV340,22IBS662; t. AMC MAJOR BASIN, Item Number: GSP158AA, Case UDI/GTIN: 40195327143511, Unit UDI/GTIN: 10195327143510, Lot Number: 22HBT951; u. AMC MAJOR BASIN, Item Number: GSP158AB, Case UDI/GTIN: 40195327252022, Unit UDI/GTIN: 10195327252021, Lot Number: 22JBD534

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 20 of 38

Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. DOUBLE BASIN CDS ff. PEDIATRIC gg. P.V.STARTER TRAY hh. CV PACK ii. MINOR GENERAL-LF jj. VASCULAR PACK-LF kk. UROLOGY PACK ll. MINOR LINEN PACK-LF mm. ABDOMINAL PACK-LF nn. MINOR SURGICAL SETUP PACK-LF oo. MINOR GENERAL PACK-LF pp. MAJOR ABDOMINAL PACK-LF qq. MINOR VASCULAR PACK-LF rr. MAJOR BASIN PACK-LF ss. DAVINCI PACK-LF tt. MINOR ENT HARPER PACK-LF uu. CHOM START UP PACK-LF vv. MINOR HARPER PACK-LF ww. MAJOR ENT HARPER PACK-LF xx. THROMBECTOMY HARPER PACK-LF yy. PENILE PROSTHESIS HARPER PK-LF zz. RECONSTRUCTIVE PACK-LF aaa. CUSTOM COLIC PACK bbb. MAJOR PACK ccc. ROBOTIC PACK ddd. MINOR PACK eee. MINOR PACK-LF fff. CT THORACIC PACK ggg. KIDNEY TRANSPLANT PACK-LF hhh. DAVINCI ROBOTIC PACK iii. MAJOR UNIVERSAL PACK-LF jjj. BASIC SETUP PACK-LF kkk. BASIC ABDOMINAL PACK-LF lll. PENILE IMPLANT PACK-LF mmm. VALVE UNIV OF CINN PACK-LF nnn. CABG UNIVERSITY HOSP PACK-LF ooo. AAA - UNIV ppp. LIVER TRANSPLNT UNIV CI PK-LF qqq. AV FISTULA PACK-LF rrr. MAJOR PACK-LF sss. MINOR SNGL BASIN PACK-LF ttt. MAJOR BASIN PACK-LF uuu. MAJOR PACK L-F vvv. PEDIATRIC PACK www. BASIC PACK-LF xxx. BASIC PACK-LF yyy. MAJOR PACK-LF zzz. MAJOR PACK aaaa. MINOR PACK bbbb. UPPER EXTREMITY PACK-LF cccc. MAJOR PACK-LF dddd. DR PALEY ILIZAROV PACK-LF eeee. MAJOR PACK ffff. BASIC PACK-LF gggg. MAJOR PACK hhhh. MAJOR LITHOTOMY PACK iiii. MAJOR LITHOTOMY PACK-LF jjjj. MAJOR PACK kkkk. MAJOR PACK llll. MAJOR LITHOTOMY PACK mmmm. AMC MINOR PACK-LF nnnn. MINOR PACK-LF oooo. MAJOR LITHOTOMY PACK-LF pppp. MAJOR PACK qqqq. MAJOR PACK-LF rrrr. MINOR GENERAL PACK ssss. MINOR ACUTE PACK-LF tttt. BASIC PACK uuuu. GENERAL PACK-LF vvvv. MAJOR BASIN PACK-LF wwww. VASCULAR SSC PACK xxxx. DAVINCI PACK-LF yyyy. SINGLE BASIN PLUS 1-LF zzzz. CUSTOM LID PACK-LF aaaaa. BARIATRIC PACK-LF bbbbb. SINGLE BASIN PLUS 4-LF ccccc. MINOR OR SET-UP PACK-LF ddddd. MINOR LAP PACK eeeee. TRAUMA PACK-LF fffff. MAJOR LITHOTOMY PACK-LF ggggg. MINOR LITHOTOMY PACK-LF hhhhh. MAJOR PROCEDURE PACK-LF iiiii. MINOR PROCEDURE PACK-LF jjjjj. DEEP BRAIN STIMULATION PACK kkkkk. VOORHEES SUMMIT T AND A PK-LF lllll. BASIC PACK-LF mmmmm. ASCI BASIC PACK nnnnn. GASTRIC BY PASS PACK-LF ooooo. MINOR PACK-LF ppppp. MAJOR SET-LF qqqqq. BASIC PACK-LF rrrrr. TRMC- GENERAL SURGERY PACK sssss. TRMC- PERI GYN PACK ttttt. PEDIATRIC PACK uuuuu. PENILE PROSTHESIS PK W/AUX vvvvv. ACCOLA AVR/MVR COMPONENT PACK wwwww. ACCOLA BASIC PACK xxxxx. BASIC SET UP PACK-LF yyyyy. MAJOR ABDOMINAL PK zzzzz. THOROCOTOMY PACK-LF aaaaaa. MINOR BASIN PACK bbbbbb. MINOR PROCEDURE KIT-LF cccccc. BIRTHDAY KIT-DOUBLE BASIN-LF dddddd. VASCULAR MAJOR BASIN-LF eeeeee. SINGLE BASIN PACK ffffff. MAJOR BASIN PACK-LF gggggg. GENERAL BASIC PACK hhhhhh. BASIC PACK iiiiii. MINOR PACK jjjjjj. CV PACK A-LF kkkkkk. KIDNEY PACK-LF llllll. GENERAL SURGERY PACK-LF mmmmmm. MINOR BASIC PACK-LF nnnnnn. MAJOR LAP PK-LF oooooo. PEDI PK-LF pppppp. THORACOTOMY PK qqqqqq. PLASTIC SOFT TISSUE #51-RF rrrrrr. ADULT LIVER TRANSPLANT PK ssssss. THORACIC-RF-LF tttttt. BASIC SET UP PACK uuuuuu. MINOR BASIC TRAY SC-LF vvvvvv. BASIC MAJOR PACK-LF wwwwww. ACDF PACK xxxxxx. MAJOR PACK yyyyyy. MINOR PACK-LF zzzzzz. VASCULAR PACK-LF aaaaaaa. BASIC PACK-LF bbbbbbb. CUSTOM THORACOTOMY ccccccc. PEDIATRIC BASIC MINOR PACK-LF ddddddd. MINOR HERNIA-LF eeeeeee. MAJOR PACK-LF fffffff. MINOR SET UP PACK-LF ggggggg. CORE PACK hhhhhhh. PEDIATRIC PACK-LF iiiiiii. GENERAL PA

Z-1079-2023
Recall number
Z-1079-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
62,930 cases (215,456 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/GTIN: 10889942614134, Lot Number: 22IBR514; b. LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/GTIN: 10888277749375, Lot Number: 22JMG555; c. MAJOR CDS, Item Number: CDS980178G, Case UDI/GTIN: 40888277906458, Unit UDI/GTIN: 10888277906457, Lot Number: 22JMG570,22JMC877; d. UROLOGY MINOR CDS, Item Number: CDS980371L, Case UDI/GTIN: 40195327050956, Unit UDI/GTIN: 10195327050955, Lot Number: 22HBU946; e. UROLOGY MAJOR CDS, Item Number: CDS980383O, Case UDI/GTIN: 40195327251193, Unit UDI/GTIN: 10195327251192, Lot Number: 22JBV588; f. SINGLE BASIC CDS, Item Number: CDS980389O, Case UDI/GTIN: 40195327231607, Unit UDI/GTIN: 10195327231606, Lot Number: 22JMF540; g. ORGAN RECOVERY CDS, Item Number: CDS980556F, Case UDI/GTIN: 40888277793836, Unit UDI/GTIN: 10888277793835, Lot Number: 22JBO588,22IBV960; h. GENERAL ABD CDS, Item Number: CDS980628I, Case UDI/GTIN: 40193489540667, Unit UDI/GTIN: 10193489540666, Lot Number: 22IMG415; i. BURN CDS, Item Number: CDS980629J, Case UDI/GTIN: 40193489540377, Unit UDI/GTIN: 10193489540376, Lot Number: 22JMG578; j. MINOR, Item Number: CDS980749G, Case UDI/GTIN: 40888277977496, Unit UDI/GTIN: 10888277977495, Lot Number: 22IBE725; k. MAJOR VASCULAR, Item Number: CDS980752I, Case UDI/GTIN: 40889942428541, Unit UDI/GTIN: 10889942428540, Lot Number: 22JBU157,22JBB126; l. BASIC CORE CDS, Item Number: CDS982062F, Case UDI/GTIN: 40193489648431, Unit UDI/GTIN: 10193489648430, Lot Number: 22JBP662,22JBO884; m. ROBOTIC PROCEDURE, Item Number: CDS982128O, Case UDI/GTIN: 40193489775533, Unit UDI/GTIN: 10193489775532, Lot Number: 22JBO084,22JBJ689; n. MAJOR VASCULAR CDS, Item Number: CDS982613G, Case UDI/GTIN: 40888277737076, Unit UDI/GTIN: 10888277737075, Lot Number: 22JBK713; o. PEDI LITHOTOMY, Item Number: CDS982718K, Case UDI/GTIN: 40193489418201, Unit UDI/GTIN: 10193489418200, Lot Number: 22JBR860,22JBK829,22IBH995; p. MAJOR CDS-1, Item Number: CDS982898G, Case UDI/GTIN: 40889942217411, Unit UDI/GTIN: 10889942217410, Lot Number: 22IBO658,22IBN353,22IBF023; q. MINOR CDS-1, Item Number: CDS982899F, Case UDI/GTIN: 40889942216933, Unit UDI/GTIN: 10889942216932, Lot Number: 22KBD131,22IBU676,22IBD867; r. VASCULAR CDS-4, Item Number: CDS983003F, Case UDI/GTIN: 40889942217459, Unit UDI/GTIN: 10889942217458, Lot Number: 22JBG357,22IBQ259; s. SEPTOPLASTY CDS, Item Number: CDS983100C, Case UDI/GTIN: 40889942926764, Unit UDI/GTIN: 10889942926763, Lot Number: 22JBB204; t. DENTAL CDS, Item Number: CDS983103C, Case UDI/GTIN: 40889942926672, Unit UDI/GTIN: 10889942926671, Lot Number: 22JBR350,22JBO090,22JBJ684; u. MINOR GENERAL CDS, Item Number: CDS983109F, Case UDI/GTIN: 40193489202343, Unit UDI/GTIN: 10193489202342, Lot Number: 22KBF514,22JBD721; v. CUH UROLOGY LITHOTOMY CDS, Item Number: CDS983180L, Case UDI/GTIN: 40195327179626, Unit UDI/GTIN: 10195327179625, Lot Number: 22JBM355; w. CUH UROLOGY OPEN CDS, Item Number: CDS983191G, Case UDI/GTIN: 40888277781673, Unit UDI/GTIN: 10888277781672, Lot Number: 22JBM356,22IBC756; x. CUH LIVER TRANSPLANT CDS, Item Number: CDS983654K, Case UDI/GTIN: 40195327164561, Unit UDI/GTIN: 10195327164560, Lot Number: 22JBO589; y. THORACOTOMY CDS, Item Number: CDS983692K, Case UDI/GTIN: 40193489953573, Unit UDI/GTIN: 10193489953572, Lot Number: 22JBR359; z. XI THORACIC ROBOTIC CDS, Item Number: CDS984338K, Case UDI/GTIN: 40195327221240, Unit UDI/GTIN: 10195327221249, Lot Number: 22KBG387; aa. GENERAL CDS, Item Number: CDS984628L, Case UDI/GTIN: 40195327070763, Unit UDI/GTIN: 10195327070762, Lot Number: 22JBH835,22IBU580; bb. THORACIC CDS, Item Number: CDS984637F, Case UDI/GTIN: 40193489861441, Unit UDI/GTIN: 10193489861440, Lot Number: 22IBF812,22IBD913,22IBA427; cc. MINOR PROCEDURE, Item Number: CDS984897J, Case UDI/GTIN: 40193489983846, Unit UDI/GTIN: 10193489983845, Lot Number: 22JBC519; dd. EXTREMITY CDS, Item Number: CDS985203B, Case UDI/GTIN: 40889942941613, Unit UDI/GTIN: 10889942941612, Lot Number: 22JBE301,22JBA666; ee. DOUBLE BASIN CDS, Item Number: CDS985205B, Case UDI/GTIN: 40889942941620, Unit UDI/GTIN: 10889942941629, Lot Number: 22KBH397; ff. PEDIATRIC, Item Number: CDS985465D, Case UDI/GTIN: 40195327090785, Unit UDI/GTIN: 10195327090784, Lot Number: 22IDA937; gg. P.V.STARTER TRAY, Item Number: CV6222T, Case UDI/GTIN: 40193489314626, Unit UDI/GTIN: 10193489314625, Lot Number: 22JLA509,22ILA422; hh. CV PACK, Item Number: CVT079R, Case UDI/GTIN: 40193489215619, Unit UDI/GTIN: 10193489215618, Lot Number: 22JBJ591; ii. MINOR GENERAL-LF, Item Number: DYNJ00199D, Case UDI/GTIN: 40884389429991, Unit UDI/GTIN: 10884389429990, Lot Number: 22IBN962; jj. VASCULAR PACK-LF, Item Number: DYNJ00203D, Case UDI/GTIN: 40888277206459, Unit UDI/GTIN: 10888277206458, Lot Number: 22IBT212; kk. UROLOGY PACK, Item Number: DYNJ01038J, Case UDI/GTIN: 40889942864820, Unit UDI/GTIN: 10889942864829, Lot Number: 22JDA606; ll. MINOR LINEN PACK-LF, Item Number: DYNJ0112530T, Case UDI/GTIN: 40195327115785, Unit UDI/GTIN: 10195327115784, Lot Number: 22JMI192; mm. ABDOMINAL PACK-LF, Item Number: DYNJ0149594F, Case UDI/GTIN: 40193489730228, Unit UDI/GTIN: 10193489730227, Lot Number: 22IMI490,22HME197; nn. MINOR SURGICAL SETUP PACK-LF, Item Number: DYNJ0151516B, Case UDI/GTIN: 40889942216346, Unit UDI/GTIN: 10889942216345, Lot Number: 22HDC003; oo. MINOR GENERAL PACK-LF, Item Number: DYNJ0159495C, Case UDI/GTIN: 40889942214427, Unit UDI/GTIN: 10889942214426, Lot Number: 22IDB673; pp. MAJOR ABDOMINAL PACK-LF, Item Number: DYNJ0159548D, Case UDI/GTIN: 40193489207447, Unit UDI/GTIN: 10193489207446, Lot Number: 22JDA012,22HDB747; qq. MINOR VASCULAR PACK-LF, Item Number: DYNJ0160151A, Case UDI/GTIN: 40889942051725, Unit UDI/GTIN: 10889942051724, Lot Number: 22JDC189,22IDB468; rr. MAJOR BASIN PACK-LF, Item Number: DYNJ0160289A, Case UDI/GTIN: 40889942051749, Unit UDI/GTIN: 10889942051748, Lot Number: 22JDC198; ss. DAVINCI PACK-LF, Item Number: DYNJ0160306D, Case UDI/GTIN: 40193489521352, Unit UDI/GTIN: 10193489521351, Lot Number: 22JDC152,22IDA021; tt. MINOR ENT HARPER PACK-LF, Item Number: DYNJ0160700D, Case UDI/GTIN: 40193489205597, Unit UDI/GTIN: 10193489205596, Lot Number: 22IDC074,22IDA779,22IDA853,22IDA192,22HDB958; uu. CHOM START UP PACK-LF, Item Number: DYNJ0161358B, Case UDI/GTIN: 40889942213260, Unit UDI/GTIN: 10889942213269, Lot Number: 22JDC165; vv. MINOR HARPER PACK-LF, Item Number: DYNJ0161694D, Case UDI/GTIN: 40889942219620, Unit UDI/GTIN: 10889942219629, Lot Number: 22IDB272,22IDA785; ww. MAJOR ENT HARPER PACK-LF, Item Number: DYNJ0161710F, Case UDI/GTIN: 40193489205573, Unit UDI/GTIN: 10193489205572, Lot Number: 22JDC154,22IDA194; xx. THROMBECTOMY HARPER PACK-LF, Item Number: DYNJ0161832D, Case UDI/GTIN: 40193489205559, Unit UDI/GTIN: 10193489205558, Lot Number: 22IDB848,22IDA001; yy. PENILE PROSTHESIS HARPER PK-LF, Item Number: DYNJ0161854C, Case UDI/GTIN: 40193489205429, Unit UDI/GTIN: 10193489205428, Lot Number: 22JDA162; zz. RECONSTRUCTIVE PACK-LF, Item Number: DYNJ0185115N, Case UDI/GTIN: 40193489376389, Unit UDI/GTIN: 10193489376388, Lot Number: 22HME609; aaa. CUSTOM COLIC PACK, Item Number: DYNJ0190097D, Case UDI/GTIN: 40193489357500, Unit UDI/GTIN: 10193489357509, Lot Number: 22IMB627; bbb. MAJOR PACK, Item Number: DYNJ01922K, Case UDI/GTIN: 40193489775564, Unit UDI/GTIN: 10193489775563, Lot Number: 22HBF615; ccc. ROBOTIC PACK, Item Number: DYNJ02314G, Case UDI/GTIN: 40193489669696, Unit UDI/GTIN: 10193489669695, Lot Number: 22IMD665; ddd. MINOR PACK, Item Number: DYNJ02480D, Case UDI/GTIN: 40193489775625, Unit UDI/GTIN: 10193489775624, Lot Number: 22JBO134; eee. MINOR PACK-LF, Item Number: DYNJ0259893S, Case UDI/GTIN: 40193489506960, Unit UDI/GTIN: 10193489506969, Lot Number: 22IMF443; fff. CT THORACIC PACK, Item Number: DYNJ0271168Q, Case UDI/GTIN: 40195327089277, Unit UDI/GTIN: 10195327089276, Lot Number: 22JBK798,22IBF123; ggg. KIDNEY TRANSPLANT PACK-LF, Item Number: DYNJ0282000U, Case UDI/GTIN: 40195327088485, Unit UDI/GTIN: 10195327088484, Lot Number: 22JDB414,22JDA237; hhh. DAVINCI ROBOTIC PACK, Item Number: DYNJ02857C, Case UDI/GTIN: 40888277743657, Unit UDI/GTIN: 10888277743656, Lot Number: 22IMC528; iii. MAJOR UNIVERSAL PACK-LF, Item Number: DYNJ0341046F, Case UDI/GTIN: 40193489735094, Unit UDI/GTIN: 10193489735093, Lot Number: 22IME563,22HMC086; jjj. BASIC SETUP PACK-LF, Item Number: DYNJ0371494M, Case UDI/GTIN: 40889942492955, Unit UDI/GTIN: 10889942492954, Lot Number: 22IMH376; kkk. BASIC ABDOMINAL PACK-LF, Item Number: DYNJ0374119M, Case UDI/GTIN: 40889942902133, Unit UDI/GTIN: 10889942902132, Lot Number: 22JBY441,22JBO082,22HBT994; lll. PENILE IMPLANT PACK-LF, Item Number: DYNJ0374945M, Case UDI/GTIN: 40193489466721, Unit UDI/GTIN: 10193489466720, Lot Number: 22HBY419; mmm. VALVE UNIV OF CINN PACK-LF, Item Number: DYNJ0375673L, Case UDI/GTIN: 40193489544122, Unit UDI/GTIN: 10193489544121, Lot Number: 22IBL136; nnn. CABG UNIVERSITY HOSP PACK-LF, Item Number: DYNJ0375705L, Case UDI/GTIN: 40193489544139, Unit UDI/GTIN: 10193489544138, Lot Number: 22JBO601; ooo. AAA - UNIV, Item Number: DYNJ0375731N, Case UDI/GTIN: 40193489423229, Unit UDI/GTIN: 10193489423228, Lot Number: 22JBI941; ppp. LIVER TRANSPLNT UNIV CI PK-LF, Item Number: DYNJ0376001O, Case UDI/GTIN: 40193489544207, Unit UDI/GTIN: 10193489544206, Lot Number: 22IBG362; qqq. AV FISTULA PACK-LF, Item Number: DYNJ0376614I, Case UDI/GTIN: 40889942419662, Unit UDI/GTIN: 10889942419661, Lot Number: 22JMH867; rrr. MAJOR PACK-LF, Item Number: DYNJ0378191M, Case UDI/GTIN: 40889942469339, Unit UDI/GTIN: 10889942469338, Lot Number: 22HME980; sss. MINOR SNGL BASIN PACK-LF, Item Number: DYNJ0379441D, Case UDI/GTIN: 40193489348058, Unit UDI/GTIN: 10193489348057, Lot Number: 22IMB634; ttt. MAJOR BASIN PACK-LF, Item Number: DYNJ0381555J, Case UDI/GTIN: 40193489475365, Unit UDI/GTIN: 10193489475364, Lot Number: 22JBO287; uuu. MAJOR PACK L-F, Item Number: DYNJ0382730L, Case UDI/GTIN: 40193489899291, Unit UDI/GTIN: 10193489899290, Lot Number: 22JMG763,22IMG639; vvv. PEDIATRIC PACK, Item Number: DYNJ0382751P, Case UDI/GTIN: 40193489899307, Unit UDI/GTIN: 10193489899306, Lot Number: 22JME325; www. BASIC PACK-LF, Item Number: DYNJ0382788P, Case UDI/GTIN: 40193489899314, Unit UDI/GTIN: 10193489899313, Lot Number: 22JMA518,22IMB261; xxx. BASIC PACK-LF, Item Number: DYNJ0387695D, Case UDI/GTIN: 40195327270149, Unit UDI/GTIN: 10195327270148, Lot Number: 22JMI200; yyy. MAJOR PACK-LF, Item Number: DYNJ0400297K, Case UDI/GTIN: 40889942402374, Unit UDI/GTIN: 10889942402373, Lot Number: 22JMG608,22IMH378; zzz. MAJOR PACK, Item Number: DYNJ04379K, Case UDI/GTIN: 40193489552011, Unit UDI/GTIN: 10193489552010, Lot Number: 22IMI201,22HME526; aaaa. MINOR PACK, Item Number: DYNJ04380J, Case UDI/GTIN: 40193489552028, Unit UDI/GTIN: 10193489552027, Lot Number: 22JMC853,22JMC970; bbbb. UPPER EXTREMITY PACK-LF, Item Number: DYNJ04438L, Case UDI/GTIN: 40888277753380, Unit UDI/GTIN: 10888277753389, Lot Number: 22JMB708; cccc. MAJOR PACK-LF, Item Number: DYNJ04443L, Case UDI/GTIN: 40193489554183, Unit UDI/GTIN: 10193489554182, Lot Number: 22JMC971,22JMB709,22HMC674; dddd. DR PALEY ILIZAROV PACK-LF, Item Number: DYNJ0445416N, Case UDI/GTIN: 40193489899260, Unit UDI/GTIN: 10193489899269, Lot Number: 22HBT955,22HBT622; eeee. MAJOR PACK, Item Number: DYNJ04459L, Case UDI/GTIN: 40195327032389, Unit UDI/GTIN: 10195327032388, Lot Number: 22JMC972,22IMB642; ffff. BASIC PACK-LF, Item Number: DYNJ04514M, Case UDI/GTIN: 40888277744067, Unit UDI/GTIN: 10888277744066, Lot Number: 22JMC973; gggg. MAJOR PACK, Item Number: DYNJ04524F, Case UDI/GTIN: 40888277744234, Unit UDI/GTIN: 10888277744233, Lot Number: 22JMH182; hhhh. MAJOR LITHOTOMY PACK, Item Number: DYNJ04541M, Case UDI/GTIN: 40193489553544, Unit UDI/GTIN: 10193489553543, Lot Number: 22JMA298; iiii. MAJOR LITHOTOMY PACK-LF, Item Number: DYNJ04602I, Case UDI/GTIN: 40193489552714, Unit UDI/GTIN: 10193489552713, Lot Number: 22HMF017; jjjj. MAJOR PACK, Item Number: DYNJ04603J, Case UDI/GTIN: 40193489552684, Unit UDI/GTIN: 10193489552683, Lot Number: 22JMI401,22JMA063,22IMA582; kkkk. MAJOR PACK, Item Number: DYNJ04623N, Case UDI/GTIN: 40193489428361, Unit UDI/GTIN: 10193489428360, Lot Number: 22IMI069; llll. MAJOR LITHOTOMY PACK, Item Number: DYNJ04632J, Case UDI/GTIN: 40193489428408, Unit UDI/GTIN: 10193489428407, Lot Number: 22JMF395; mmmm. AMC MINOR PACK-LF, Item Number: DYNJ0464207X, Case UDI/GTIN: 40195327007998, Unit UDI/GTIN: 10195327007997, Lot Number: 22JMA632; nnnn. MINOR PACK-LF, Item Number: DYNJ04713U, Case UDI/GTIN: 40193489443555, Unit UDI/GTIN: 10193489443554, Lot Number: 22JME051,22HME263; oooo. MAJOR LITHOTOMY PACK-LF, Item Number: DYNJ04716U, Case UDI/GTIN: 40193489448048, Unit UDI/GTIN: 10193489448047, Lot Number: 22JMF082; pppp. MAJOR PACK, Item Number: DYNJ04720R, Case UDI/GTIN: 40193489443487, Unit UDI/GTIN: 10193489443486, Lot Number: 22HMG409; qqqq. MAJOR PACK-LF, Item Number: DYNJ04796I, Case UDI/GTIN: 40888277746443, Unit UDI/GTIN: 10888277746442, Lot Number: 22JMA435; rrrr. MINOR GENERAL PACK, Item Number: DYNJ04831O, Case UDI/GTIN: 40888277748133, Unit UDI/GTIN: 10888277748132, Lot Number: 22JMB281; ssss. MINOR ACUTE PACK-LF, Item Number: DYNJ0484979D, Case UDI/GTIN: 40193489822695, Unit UDI/GTIN: 10193489822694, Lot Number: 22JMD507; tttt. BASIC PACK, Item Number: DYNJ04876N, Case UDI/GTIN: 40195327208180, Unit UDI/GTIN: 10195327208189, Lot Number: 22IMB648; uuuu. GENERAL PACK-LF, Item Number: DYNJ0506906R, Case UDI/GTIN: 40193489507066, Unit UDI/GTIN: 10193489507065, Lot Number: 22JMA172,22HMF233; vvvv. MAJOR BASIN PACK-LF, Item Number: DYNJ0515994P, Case UDI/GTIN: 40193489397759, Unit UDI/GTIN: 10193489397758, Lot Number: 22IMB444; wwww. VASCULAR SSC PACK, Item Number: DYNJ0537007K, Case UDI/GTIN: 40889942794264, Unit UDI/GTIN: 10889942794263, Lot Number: 22KBA498,22IBR500,22HBY097; xxxx. DAVINCI PACK-LF, Item Number: DYNJ0556546C, Case UDI/GTIN: 40193489397681, Unit UDI/GTIN: 10193489397680, Lot Number: 22IMF639; yyyy. SINGLE BASIN PLUS 1-LF, Item Number: DYNJ06003, Case UDI/GTIN: 40080196990291, Unit UDI/GTIN: 10080196990290, Lot Number: 22JDA756; zzzz. CUSTOM LID PACK-LF, Item Number: DYNJ06672I, Case UDI/GTIN: 40889942725831, Unit UDI/GTIN: 10889942725830, Lot Number: 22JBW650,22HBV204; aaaaa. BARIATRIC PACK-LF, Item Number: DYNJ0674223C, Case UDI/GTIN: 40888277794994, Unit UDI/GTIN: 10888277794993, Lot Number: 22IMI110,22HMC796; bbbbb. SINGLE BASIN PLUS 4-LF, Item Number: DYNJ06803, Case UDI/GTIN: 40080196820550, Unit UDI/GTIN: 10080196820559, Lot Number: 22JBF173,22HBG927; ccccc. MINOR OR SET-UP PACK-LF, Item Number: DYNJ0696294G, Case UDI/GTIN: 40193489723251, Unit UDI/GTIN: 10193489723250, Lot Number: 22JMC550,22JMC473,22IMF641,22HMD559; ddddd. MINOR LAP PACK, Item Number: DYNJ07513D, Case UDI/GTIN: 40080196940807, Unit UDI/GTIN: 10080196940806, Lot Number: 22HMC058; eeeee. TRAUMA PACK-LF, Item Number: DYNJ0781508Q, Case UDI/GTIN: 40193489226554, Unit UDI/GTIN: 10193489226553, Lot Number: 22IMI416,22IMB663; fffff. MAJOR LITHOTOMY PACK-LF, Item Number: DYNJ0781758AI, Case UDI/GTIN: 40193489225984, Unit UDI/GTIN: 10193489225983, Lot Number: 22JMB722; ggggg. MINOR LITHOTOMY PACK-LF, Item Number: DYNJ0781764V, Case UDI/GTIN: 40193489225991, Unit UDI/GTIN: 10193489225990, Lot Number: 22IMC057; hhhhh. MAJOR PROCEDURE PACK-LF, Item Number: DYNJ0826667P, Case UDI/GTIN: 40193489265706, Unit UDI/GTIN: 10193489265705, Lot Number: 22JME723,22IMC058; iiiii. MINOR PROCEDURE PACK-LF, Item Number: DYNJ0826673M, Case UDI/GTIN: 40193489266949, Unit UDI/GTIN: 10193489266948, Lot Number: 22JMF339; jjjjj. DEEP BRAIN STIMULATION PACK, Item Number: DYNJ0842793F, Case UDI/GTIN: 40193489345231, Unit UDI/GTIN: 10193489345230, Lot Number: 22IDC164; kkkkk. VOORHEES SUMMIT T AND A PK-LF, Item Number: DYNJ0858334B, Case UDI/GTIN: 40889942137368, Unit UDI/GTIN: 10889942137367, Lot Number: 22JBT360,22IBT213; lllll. BASIC PACK-LF, Item Number: DYNJ0923000, Case UDI/GTIN: 40889942099628, Unit UDI/GTIN: 10889942099627, Lot Number: 22IMG974; mmmmm. ASCI BASIC PACK, Item Number: DYNJ09431D, Case UDI/GTIN: 40080196844419, Unit UDI/GTIN: 10080196844418, Lot Number: 22JBV949; nnnnn. GASTRIC BY PASS PACK-LF, Item Number: DYNJ0945440C, Case UDI/GTIN: 40889942902140, Unit UDI/GTIN: 10889942902149, Lot Number: 22JMH773; ooooo. MINOR PACK-LF, Item Number: DYNJ0958339B, Case UDI/GTIN: 40888277795854, Unit UDI/GTIN: 10888277795853, Lot Number: 22IMG335,22IME723; ppppp. MAJOR SET-LF, Item Number: DYNJ09684F, Case UDI/GTIN: 40888277860279, Unit UDI/GTIN: 10888277860278, Lot Number: 22IBL369; qqqqq. BASIC PACK-LF, Item Number: DYNJ09819L, Case UDI/GTIN: 40888277841209, Unit UDI/GTIN: 10888277841208, Lot Number: 22JBG421; rrrrr. TRMC- GENERAL SURGERY PACK, Item Number: DYNJ10121D, Case UDI/GTIN: 40195327133284, Unit UDI/GTIN: 10195327133283, Lot Number: 22HBY227,22HBZ360; sssss. TRMC- PERI GYN PACK, Item Number: DYNJ10127C, Case UDI/GTIN: 40193489742870, Unit UDI/GTIN: 10193489742879, Lot Number: 22JBI432,22HBZ361; ttttt. PEDIATRIC PACK, Item Number: DYNJ14037D, Case UDI/GTIN: 40884389599724, Unit UDI/GTIN: 10884389599723, Lot Number: 22JBC760,22IBI913,22IBA979; uuuuu. PENILE PROSTHESIS PK W/AUX, Item Number: DYNJ14038F, Case UDI/GTIN: 40884389872858, Unit UDI/GTIN: 10884389872857, Lot Number: 22IBA891,22IBA896; vvvvv. ACCOLA AVR/MVR COMPONENT PACK, Item Number: DYNJ14052D, Case UDI/GTIN: 40888277538680, Unit UDI/GTIN: 10888277538689, Lot Number: 22HBN112; wwwww. ACCOLA BASIC PACK, Item Number: DYNJ14053D, Case UDI/GTIN: 40884389650050, Unit UDI/GTIN: 10884389650059, Lot Number: 22HBL398; xxxxx. BASIC SET UP PACK-LF, Item Number: DYNJ14075D, Case UDI/GTIN: 40193489927666, Unit UDI/GTIN: 10193489927665, Lot Number: 22IBK166,22HBT045; yyyyy. MAJOR ABDOMINAL PK, Item Number: DYNJ14176L, Case UDI/GTIN: 40193489618663, Unit UDI/GTIN: 10193489618662, Lot Number: 22JBP989,22JBF108,22IBS321; zzzzz. THOROCOTOMY PACK-LF, Item Number: DYNJ14185C, Case UDI/GTIN: 40884389606910, Unit UDI/GTIN: 10884389606919, Lot Number: 22IBH271; aaaaaa. MINOR BASIN PACK, Item Number: DYNJ14226A, Case UDI/GTIN: 40884389427430, Unit UDI/GTIN: 10884389427439, Lot Number: 22IBI885; bbbbbb. MINOR PROCEDURE KIT-LF, Item Number: DYNJ15902J, Case UDI/GTIN: 40888277858481, Unit UDI/GTIN: 10888277858480, Lot Number: 22JBH671,22IBU549,22HBN979; cccccc. BIRTHDAY KIT-DOUBLE BASIN-LF, Item Number: DYNJ16127L, Case UDI/GTIN: 40889942225232, Unit UDI/GTIN: 10889942225231, Lot Number: 22JBH237,22HBU472; dddddd. VASCULAR MAJOR BASIN-LF, Item Number: DYNJ16280G, Case UDI/GTIN: 40888277858610, Unit UDI/GTIN: 10888277858619, Lot Number: 22JBI144; eeeeee. SINGLE BASIN PACK, Item Number: DYNJ16288C, Case UDI/GTIN: 40080196799467, Unit UDI/GTIN: 10080196799466, Lot Number: 22HBY849; ffffff. MAJOR BASIN PACK-LF, Item Number: DYNJ16474F, Case UDI/GTIN: 40193489313346, Unit UDI/GTIN: 10193489313345, Lot Number: 22JBY663; gggggg. GENERAL BASIC PACK, Item Number: DYNJ16858F, Case UDI/GTIN: 40888277749352, Unit UDI/GTIN: 10888277749351, Lot Number: 22JMC997; hhhhhh. BASIC PACK, Item Number: DYNJ17306J, Case UDI/GTIN: 40193489772372, Unit UDI/GTIN: 10193489772371, Lot Number: 22IBQ624,22HBR639,22HBO351; iiiiii. MINOR PACK, Item Number: DYNJ19845K, Case UDI/GTIN: 40888277851031, Unit UDI/GTIN: 10888277851030, Lot Number: 22KBA883,22JBA866,22IBK831,22HBX775; jjjjjj. CV PACK A-LF, Item Number: DYNJ19878R, Case UDI/GTIN: 40193489560030, Unit UDI/GTIN: 10193489560039, Lot Number: 22JBY143,22IBG282; kkkkkk. KIDNEY PACK-LF, Item Number: DYNJ20463K, Case UDI/GTIN: 40195327024476, Unit UDI/GTIN: 10195327024475, Lot Number: 22JDB947; llllll. GENERAL SURGERY PACK-LF, Item Number: DYNJ20464M, Case UDI/GTIN: 40195327024483, Unit UDI/GTIN: 10195327024482, Lot Number: 22JBS272; mmmmmm. MINOR BASIC PACK-LF, Item Number: DYNJ20473K, Case UDI/GTIN: 40195327024346, Unit UDI/GTIN: 10195327024345, Lot Number: 22JLA971,22HLB167; nnnnnn. MAJOR LAP PK-LF, Item Number: DYNJ21239I, Case UDI/GTIN: 40889942928256, Unit UDI/GTIN: 10889942928255, Lot Number: 22HBU863; oooooo. PEDI PK-LF, Item Number: DYNJ21240J, Case UDI/GTIN: 40889942931379, Unit UDI/GTIN: 10889942931378, Lot Number: 22HME771; pppppp. THORACOTOMY PK, Item Number: DYNJ21248M, Case UDI/GTIN: 40193489935722, Unit UDI/GTIN: 10193489935721, Lot Number: 22HBL259; qqqqqq. PLASTIC SOFT TISSUE #51-RF, Item Number: DYNJ21926O, Case UDI/GTIN: 40889942885498, Unit UDI/GTIN: 10889942885497, Lot Number: 22JBG479; rrrrrr. ADULT LIVER TRANSPLANT PK, Item Number: DYNJ22034L, Case UDI/GTIN: 40889942029076, Unit UDI/GTIN: 10889942029075, Lot Number: 22JBP763,22HBT812; ssssss. THORACIC-RF-LF, Item Number: DYNJ22231S, Case UDI/GTIN: 40193489962773, Unit UDI/GTIN: 10193489962772, Lot Number: 22IBS903,22HBX817,22HBM563; tttttt. BASIC SET UP PACK, Item Number: DYNJ22773F, Case UDI/GTIN: 40889942119388, Unit UDI/GTIN: 10889942119387, Lot Number: 22IBJ079,22HBF502; uuuuuu. MINOR BASIC TRAY SC-LF, Item Number: DYNJ23048K, Case UDI/GTIN: 40193489476645, Unit UDI/GTIN: 10193489476644, Lot Number: 22JMB936; vvvvvv. BASIC MAJOR PACK-LF, Item Number: DYNJ23058G, Case UDI/GTIN: 40193489483759, Unit UDI/GTIN: 10193489483758, Lot Number: 22JMD152,22IMC183; wwwwww. ACDF PACK, Item Number: DYNJ23339J, Case UDI/GTIN: 40889942913757, Unit UDI/GTIN: 10889942913756, Lot Number: 22IBP882; xxxxxx. MAJOR PACK, Item Number: DYNJ23530D, Case UDI/GTIN: 40193489461030, Unit UDI/GTIN: 10193489461039, Lot Number: 22JME731; yyyyyy. MINOR PACK-LF, Item Number: DYNJ24860G, Case UDI/GTIN: 40889942361619, Unit UDI/GTIN: 10889942361618, Lot Number: 22IBU038,22IBS798; zzzzzz. VASCULAR PACK-LF, Item Number: DYNJ25102G, Case UDI/GTIN: 40888277858092, Unit UDI/GTIN: 10888277858091, Lot Number: 22JBT206,22JBJ482,22IBB730; aaaaaaa. BASIC PACK-LF, Item Number: DYNJ25450I, Case UDI/GTIN: 40889942136200, Unit UDI/GTIN: 10889942136209, Lot Number: 22IBL300,22HBP606; bbbbbbb. CUSTOM THORACOTOMY, Item Number: DYNJ25984L, Case UDI/GTIN: 40889942843597, Unit UDI/GTIN: 10889942843596, Lot Number: 22JBO093,22HBW408; ccccccc. PEDIATRIC BASIC MINOR PACK-LF, Item Number: DYNJ26093N, Case UDI/GTIN: 40195327024612, Unit UDI/GTIN: 10195327024611, Lot Number: 22IDA692; ddddddd. MINOR HERNIA-LF, Item Number: DYNJ26437I, Case UDI/GTIN: 40888277785343, Unit UDI/GTIN: 10888277785342, Lot Number: 22JBN694,22IBK678; eeeeeee. MAJOR PACK-LF, Item Number: DYNJ26973G, Case UDI/GTIN: 40889942948858, Unit UDI/GTIN: 10889942948857, Lot Number: 22JBO153,22HBT046,22HBR979; fffffff. MINOR SET UP PACK-LF, Item Number: DYNJ26980F, Case UDI/GTIN: 40193489422796, Unit UDI/GTIN: 10193489422795, Lot Number: 22JBQ427; ggggggg. CORE PACK, Item Number: DYNJ27926F, Case UDI/GTIN: 40193489553599, Unit UDI/GTIN: 10193489553598, Lot Number: 22JMF086; hhhhhhh. PEDIATRIC PACK-LF, Item Number: DYNJ28212L, Case UDI/GTIN: 40193489322119, Unit UDI/GTIN: 10193489322118, Lot Number: 22JBK161,22IBC347,22HBX988,22HBX989; iiiiiii. GENERAL PACK, Item Number: DYNJ29100M, Case UDI/GTIN: 40193489854979, Unit UDI/GTIN: 10193489854978, Lot Number: 22IMG340; jjjjjjj. CHRONIC EAR PACK, Item Number: DYNJ30114K, Case UDI/GTIN: 40889942833925, Unit UDI/GTIN: 10889942833924, Lot Number: 22IBK719; kkkkkkk. MINOR, Item Number: DYNJ30223B, Case UDI/GTIN: 40889942914648, Unit UDI/GTIN: 10889942914647, Lot Number: 22JBV720,22HBP620; lllllll. EXTREMITY, Item Number: DYNJ30230B, Case UDI/GTIN: 40889942914655, Unit UDI/GTIN: 10889942914654, Lot Number: 22IBO538; mmmmmmm. GENERAL PACK, Item Number: DYNJ30550C, Case UDI/GTIN: 40889942766094, Unit UDI/GTIN: 10889942766093, Lot Number: 22KBA893,22JBC146,22HLB009; nnnnnnn. BARIATRIC PACK, Item Number: DYNJ31072I, Case UDI/GTIN: 40193489600354, Unit UDI/GTIN: 10193489600353, Lot Number: 22KMA355; ooooooo. BASIC PACK, Item Number: DYNJ32008F, Case UDI/GTIN: 40195327067053, Unit UDI/GTIN: 10195327067052, Lot Number: 22IMI099; ppppppp. DOUBLE BASIN SET-LF - 35530, Item Number: DYNJ32390G, Case UDI/GTIN: 40195327060146, Unit UDI/GTIN: 10195327060145, Lot Number: 22JBS312; qqqqqqq. ENS. BASSIN GRANDS BRULES-LF, Item Number: DYNJ32829B, Case UDI/GTIN: 40193489844949, Unit UDI/GTIN: 10193489844948, Lot Number: 22IBP605; rrrrrrr. OSC COLEMAN FAT HARVEST KIT, Item Number: DYNJ32854A, Case UDI/GTIN: 40884389736280, Unit UDI/GTIN: 10884389736289, Lot Number: 22IBI212; sssssss. VASCULAR PACK-LF, Item Number: DYNJ32915A, Case UDI/GTIN: 40884389759548, Unit UDI/GTIN: 10884389759547, Lot Number: 22IBG149; ttttttt. MAJOR PACK, Item Number: DYNJ33211C, Case UDI/GTIN: 40889942959779, Unit UDI/GTIN: 10889942959778, Lot Number: 22JMI099; uuuuuuu. BWNBORO BASIC PACK-LF, Item Number: DYNJ33406A, Case UDI/GTIN: 40195327037452, Unit UDI/GTIN: 10195327037451, Lot Number: 22IMF341; vvvvvvv. DOUBLE BASIN KIT, Item Number: DYNJ33440C, Case UDI/GTIN: 40193489457910, Unit UDI/GTIN: 10193489457919, Lot Number: 22JBG758,22IBU536; wwwwwww. ROBOTIC ADD A PACK, Item Number: DYNJ33496D, Case UDI/GTIN: 40888277744630, Unit UDI/GTIN: 10888277744639, Lot Number: 22JME744; xxxxxxx. BASIC PACK, Item Number: DYNJ33749B, Case UDI/GTIN: 40193489627788, Unit UDI/GTIN: 10193489627787, Lot Number: 22IBQ280,22HBV635; yyyyyyy. ENDO AAA PACK, Item Number: DYNJ33934B, Case UDI/GTIN: 40888277858443, Unit UDI/GTIN: 10888277858442, Lot Number: 22HBU113; zzzzzzz. BASIC PACK, Item Number: DYNJ34397A, Case UDI/GTIN: 40884389563480, Unit UDI/GTIN: 10884389563489, Lot Number: 22IBR866,22HBK262,22HBG014; aaaaaaaa. CYSTO SUSPENSION BLADDER PACK, Item Number: DYNJ34620C, Case UDI/GTIN: 40193489502634, Unit UDI/GTIN: 10193489502633, Lot Number: 22IBT221; bbbbbbbb. DOTHAN SURGERY GENERAL PACK, Item Number: DYNJ34849C, Case UDI/GTIN: 40193489781473, Unit UDI/GTIN: 10193489781472, Lot Number: 22JBB491,22IBN350; cccccccc. BASIC PACK, Item Number: DYNJ35212I, Case UDI/GTIN: 40193489889582, Unit UDI/GTIN: 10193489889581, Lot Number: 22JBG358; dddddddd. BASIC SET UP PACK ALTAMONTE, Item Number: DYNJ35429B, Case UDI/GTIN: 40889942684145, Unit UDI/GTIN: 10889942684144, Lot Number: 22JBH674,22IBB086; eeeeeeee. MINOR PROCEDURE, Item Number: DYNJ35640A, Case UDI/GTIN: 40193489595957, Unit UDI/GTIN: 10193489595956, Lot Number: 22JBQ450,22HBZ184; ffffffff. BASIC PACK, Item Number: DYNJ35738D, Case UDI/GTIN: 40889942107903, Unit UDI/GTIN: 10889942107902, Lot Number: 22IBL696,22HBL103; gggggggg. SET-UP PACK-LF, Item Number: DYNJ35847A, Case UDI/GTIN: 40884389605487, Unit UDI/GTIN: 10884389605486, Lot Number: 22JME751; hhhhhhhh. BASIN PACK-LF, Item Number: DYNJ35986B, Case UDI/GTIN: 40889942402190, Unit UDI/GTIN: 10889942402199, Lot Number: 22JBV617,22IBD119,22HBN115; iiiiiiii. BASIC PACK-LF, Item Number: DYNJ36096D, Case UDI/GTIN: 40195327080250, Unit UDI/GTIN: 10195327080259, Lot Number: 22JME253; jjjjjjjj. TYMPAMOPLASTY PACK-LF, Item Number: DYNJ36103C, Case UDI/GTIN: 40889942797654, Unit UDI/GTIN: 10889942797653, Lot Number: 22HME800; kkkkkkkk. BASIC PACK-ACCESSORY, Item Number: DYNJ36199F, Case UDI/GTIN: 40195327188215, Unit UDI/GTIN: 10195327188214, Lot Number: 22JMD016,22IMD705; llllllll. BASIN PACK-LF, Item Number: DYNJ36419C, Case UDI/GTIN: 40888277833129, Unit UDI/GTIN: 10888277833128, Lot Number: 22JBH638; mmmmmmmm. BASIC PACK, Item Number: DYNJ36595D, Case UDI/GTIN: 40193489928977, Unit UDI/GTIN: 10193489928976, Lot Number: 22IBM598,22HBO974; nnnnnnnn. SURGICAL SURE SET TRAY, Item Number: DYNJ36646, Case UDI/GTIN: 40884389557854, Unit UDI/GTIN: 10884389557853, Lot Number: 22JMF206; oooooooo. GLENNON ENT PACK, Item Number: DYNJ36755C, Case UDI/GTIN: 40889942837411, Unit UDI/GTIN: 10889942837410, Lot Number: 22JBV795,22JBD216; pppppppp. BARIATRIC PACK, Item Number: DYNJ36836C, Case UDI/GTIN: 40888277744555, Unit UDI/GTIN: 10888277744554, Lot Number: 22JMB588,22IMB681; qqqqqqqq. ROBOTIC PACK, Item Number: DYNJ36840J, Case UDI/GTIN: 40193489581172, Unit UDI/GTIN: 10193489581171, Lot Number: 22IBU398; rrrrrrrr. CORE PACK-LF, Item Number: DYNJ36907C, Case UDI/GTIN: 40888277750457, Unit UDI/GTIN: 10888277750456, Lot Number: 22IME950; ssssssss. MINOR PACK, Item Number: DYNJ36918A, Case UDI/GTIN: 40884389597423, Unit UDI/GTIN: 10884389597422, Lot Number: 22JBV814; tttttttt. BASIC PACK, Item Number: DYNJ37234D, Case UDI/GTIN: 40193489619004, Unit UDI/GTIN: 10193489619003, Lot Number: 22JMB633,22IMB683; uuuuuuuu. CAM SENT LYMPH MELANOMA PK, Item Number: DYNJ37626B, Case UDI/GTIN: 40889942029069, Unit UDI/GTIN: 10889942029068, Lot Number: 22IBV195,22HBF776; vvvvvvvv. MINOR SINGLE BASIN PACK, Item Number: DYNJ37698J, Case UDI/GTIN: 40193489782821, Unit UDI/GTIN: 10193489782820, Lot Number: 22IMI375; wwwwwwww. STR BAPTIST MEDICAL PARK KIT 1, Item Number: DYNJ37794B, Case UDI/GTIN: 40889942526728, Unit UDI/GTIN: 10889942526727, Lot Number: 22IBK680; xxxxxxxx. BASIC EXTREMITY PACK, Item Number: DYNJ37924C, Case UDI/GTIN: 40889942870388, Unit UDI/GTIN: 10889942870387, Lot Number: 22IBR187; yyyyyyyy. CUH VASC BASIN PACK II-LF, Item Number: DYNJ37931B, Case UDI/GTIN: 40889942292272, Unit UDI/GTIN: 10889942292271, Lot Number: 22JBW622,22IBJ906,22HBL999; zzzzzzzz. MAJOR SINGLE BASIN, Item Number: DYNJ38090C, Case UDI/GTIN: 40195327036745, Unit UDI/GTIN: 10195327036744, Lot Number: 22IBR395; aaaaaaaaa. GENERAL BASIC PACK, Item Number: DYNJ38117B, Case UDI/GTIN: 40193489443258, Unit UDI/GTIN: 10193489443257, Lot Number: 22JMG331; bbbbbbbbb. BASIC UROLOGY PACK, Item Number: DYNJ38246A, Case UDI/GTIN: 40884389757773, Unit UDI/GTIN: 10884389757772, Lot Number: 22IBI264; ccccccccc. MINOR SURGERY PACK, Item Number: DYNJ38446B, Case UDI/GTIN: 40193489785082, Unit UDI/GTIN: 10193489785081, Lot Number: 22JMF049,22IMH437; ddddddddd. MAJOR SURGERY PACK, Item Number: DYNJ38447C, Case UDI/GTIN: 40193489785099, Unit UDI/GTIN: 10193489785098, Lot Number: 22IMH438; eeeeeeeee. CELEBRATION BASIC PACK, Item Number: DYNJ38455, Case UDI/GTIN: 40884389693057, Unit UDI/GTIN: 10884389693056, Lot Number: 22JBH707,22IBD148; fffffffff. DERM PROCEDURE TRAY, Item Number: DYNJ38936B, Case UDI/GTIN: 40889942592228, Unit UDI/GTIN: 10889942592227, Lot Number: 22JMG965; ggggggggg. DENTAL PACK, Item Number: DYNJ39138G, Case UDI/GTIN: 40193489311120, Unit UDI/GTIN: 10193489311129, Lot Number: 22JBK171,22HBN489; hhhhhhhhh. CATH CVOR MINOR, Item Number: DYNJ39230B, Case UDI/GTIN: 40193489362832, Unit UDI/GTIN: 10193489362831, Lot Number: 22IBQ699; iiiiiiiii. BASIC PACK II, Item Number: DYNJ39401B, Case UDI/GTIN: 40193489746489, Unit UDI/GTIN: 10193489746488, Lot Number: 22JME335; jjjjjjjjj. MAJOR PROCEDURE PACK-LF, Item Number: DYNJ39404B, Case UDI/GTIN: 40193489869249, Unit UDI/GTIN: 10193489869248, Lot Number: 22IBQ879; kkkkkkkkk. MINOR PROCEDURE PACK-LF, Item Number: DYNJ39405B, Case UDI/GTIN: 40193489869232, Unit UDI/GTIN: 10193489869231, Lot Number: 22JBW797,22JBI585,22HBV257; lllllllll. SET UP PACK, Item Number: DYNJ39543D, Case UDI/GTIN: 40888277744791, Unit UDI/GTIN: 10888277744790, Lot Number: 22IMH848; mmmmmmmmm. LOWER EXTREMITY PACK, Item Number: DYNJ39652B, Case UDI/GTIN: 40889942540038, Unit UDI/GTIN: 10889942540037, Lot Number: 22JMB111; nnnnnnnnn. C SECTION PACK, Item Number: DYNJ39655D, Case UDI/GTIN: 40889942539919, Unit UDI/GTIN: 10889942539918, Lot Number: 22HBR159; ooooooooo. MAJOR PACK, Item Number: DYNJ39658A, Case UDI/GTIN: 40888277549068, Unit UDI/GTIN: 10888277549067, Lot Number: 22HMF162; ppppppppp. MINI KIT, Item Number: DYNJ39710A, Case UDI/GTIN: 40889942916826, Unit UDI/GTIN: 10889942916825, Lot Number: 22JMG049,22HMC691; qqqqqqqqq. SCOPE PACK, Item Number: DYNJ39728B, Case UDI/GTIN: 40193489728492, Unit UDI/GTIN: 10193489728491, Lot Number: 22JBP979,22IBG614; rrrrrrrrr. LIVER TRANSPLANT A & B GH-LF, Item Number: DYNJ39851C, Case UDI/GTIN: 40195327176939, Unit UDI/GTIN: 10195327176938, Lot Number: 22JME762; sssssssss. HL HAND-UPPER PACK, Item Number: DYNJ40362B, Case UDI/GTIN: 40193489372367, Unit UDI/GTIN: 10193489372366, Lot Number: 22IBP949,22HBP195; ttttttttt. HL ORAL SURGERY PACK, Item Number: DYNJ40369A, Case UDI/GTIN: 40889942530985, Unit UDI/GTIN: 10889942530984, Lot Number: 22IBD444; uuuuuuuuu. HL VASO PACK, Item Number: DYNJ40373A, Case UDI/GTIN: 40889942531029, Unit UDI/GTIN: 10889942531028, Lot Number: 22JBL516,22HBF897; vvvvvvvvv. ORGAN RECOVERY PACK, Item Number: DYNJ40378D, Case UDI/GTIN: 40193489846608, Unit UDI/GTIN: 10193489846607, Lot Number: 22JBO132,22HBW664; wwwwwwwww. AMPUTATION PACK, Item Number: DYNJ40381A, Case UDI/GTIN: 408

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 21 of 38

Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK

Z-1080-2023
Recall number
Z-1080-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
26 cases (104 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. UNIVERSAL PLASTIC, Item Number: DYNJ04047C, Case UDI/GTIN: 40888277855060, Unit UDI/GTIN: 10888277855069, Lot Number: 22IBH860,22IBJ054; b. KNEE ARTHROSCOPY PACK, Item Number: DYNJ24784C, Case UDI/GTIN: 40889942732587, Unit UDI/GTIN: 10889942732586, Lot Number: 22JBM001;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 22 of 38

Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK

Z-1081-2023
Recall number
Z-1081-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
36 cases (116 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. WOUND CLOSURE TRAY, Item Number: DYNJ56703, Case UDI/GTIN: 40889942672418, Unit UDI/GTIN: 10889942672417, Lot Number: 22JBE355; b. WOUND PACK, Item Number: DYNJ80201A, Case UDI/GTIN: 40195327171538, Unit UDI/GTIN: 10195327171537, Lot Number: 22IBE619

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 23 of 38

Sterile Procedural Trays, labeled as the following: IM NAIL

Z-1082-2023
Recall number
Z-1082-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
40 cases (40 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ901391D, Case UDI/GTIN: 40193489436595, Unit UDI/GTIN: 10193489436594, Lot Number: 22KBH254, 22IBI253

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 24 of 38

Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN

Z-1083-2023
Recall number
Z-1083-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
100 cases (156 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. MAJOR CDS-LF, Item Number: CDS983861D, Case UDI/GTIN: 40193489524353, Unit UDI/GTIN: 10193489524352, Lot Number: 22JDB004; b. BURN PACK-LF, Item Number: DYNJ0781678S, Case UDI/GTIN: 40193489226349, Unit UDI/GTIN: 10193489226348, Lot Number: 22IMC056; c. BURN PACK, Item Number: DYNJ82534, Case UDI/GTIN: 40195327198504, Unit UDI/GTIN: 10195327198503, Lot Number: 22HBI219; d. SMALL BURN, Item Number: DYNJ901793L, Case UDI/GTIN: 40193489955065, Unit UDI/GTIN: 10193489955064, Lot Number: 22KBB743,22IBH124

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 25 of 38

Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF

Z-1084-2023
Recall number
Z-1084-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
50 cases (200 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ0281516M, Case UDI/GTIN: 40889942056676, Unit UDI/GTIN: 10889942056675, Lot Number: 22JMA630,22HMC805;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 26 of 38

Sterile Procedural Trays, labeled as the following: LS MS PACK

Z-1085-2023
Recall number
Z-1085-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
159 cases (159 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ81738, Case UDI/GTIN: 40195327138258, Unit UDI/GTIN: 10195327138257, Lot Number: 22IBO057

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 27 of 38

Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK

Z-1086-2023
Recall number
Z-1086-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
5 cases (5 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ42065B, Case UDI/GTIN: 40888277893550, Unit UDI/GTIN: 10888277893559, Lot Number: 22JLA859

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 28 of 38

Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK

Z-1087-2023
Recall number
Z-1087-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
36 cases (216 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

Item Number: DYNJ82579, Case UDI/GTIN: 40195327198153, Unit UDI/GTIN: 10195327198152, Lot Number: 22HBQ045

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 29 of 38

Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l. U H S NEURO PACK SC m. NEURO PACK-CELEBRATION n. NEURO PACK o. NEURO BASIN PACK-LF p. NEURO PACK q. MAJOR NEURO PK-LF r. NINOR NEURO PK-LF s. NEURO VP SHUNT/VAGAL NERVE-RF t. NEURO PACK-LF u. NEURO PACK v. CRANIOTOMY w. PEDIATRIC NEURO PACK x. NEURO MATRIX PACK y. ACOUSTIC NEUROMA PACK-LF z. MAJOR NEURO PACK-LF aa. SCRIPPS SW NEURO PACK-LF bb. NEURO PACK cc. GENERAL PACK dd. NEURO PK ee. NEURO PACK ff. NEURO PACK gg. NEURO PACK hh. NEURO PACK-LF ii. NEURO PACK jj. NEURO PACK kk. NEURO PACK ll. NEURO PACK mm. CRANIOTOMY PACK nn. PK, NEURO-MINOR oo. NEURO PACK pp. NEURO PACK qq. NEURO PACK rr. PK, NEURO-MINOR ss. NEURO BASIC tt. NEURO BASIC uu. CRANIOTOMY PACK (CRSJE)227-LF vv. NEURO PACK ww. NEURO PACK xx. NEURO CRANI PACK yy. NEURO PACK zz. NEURO TRAY-LF aaa. NEURO PACK bbb. WH NEURO PACK ccc. RFT ISC-N NEURO PACK ddd. NEURO-LF eee. NEURO PACK fff. NEURO LUMBAR PACK ggg. NEURO FUSION PACK-LF hhh. NEURO CERVICAL PACK iii. NEURO PACK jjj. VP SHUNT PACK kkk. NEURO BASIC PACK lll. NEURO PACK mmm. CHRISTUS CHILDRENS NEURO PK nnn. CHRISTUS CHILDRENS VP SHUNT PK ooo. RF NEURO-SHUNT PACK ppp. NEURO PACK qqq. NEURO PACK rrr. NEURO ST DAVIDS MEDICAL CTR sss. GIO NEURO PACK ttt. NEURO KIT uuu. DISCECTOMY PACK vvv. NEURO PACK www. BASIC NEURO PACK-LF xxx. NEURO PACK yyy. NEURO PACK zzz. NEURO aaaa. NEURO bbbb. FHCW NEURO PACK cccc. NEURO FERREE dddd. NEURO eeee. NEURO PACK CW ffff. NEURO gggg. FHT NEURO hhhh. NEURO BASIC iiii. NEURO LUMBAR jjjj. NCH NEURO kkkk. TAVI llll. CHN OR NEURO mmmm. NEURO PACK-LF nnnn. NEURO-CRANI-LF

Z-1088-2023
Recall number
Z-1088-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
6,782 cases (15,253 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. AV SHUNT CDS, Item Number: CDS983098D, Case UDI/GTIN: 40195327191307, Unit UDI/GTIN: 10195327191306, Lot Number: 22IBD957; b. ZALE V-P SHUNT CDS, Item Number: CDS983186J, Case UDI/GTIN: 40195327105625, Unit UDI/GTIN: 10195327105624, Lot Number: 22IBT194; c. NEURO CDS-LF, Item Number: CDS985289, Case UDI/GTIN: 40888277050502, Unit UDI/GTIN: 10888277050501, Lot Number: 22JBH363,22IBF823,22IBD861; d. MAJOR NEURO, Item Number: CDS985548N, Case UDI/GTIN: 40195327033256, Unit UDI/GTIN: 10195327033255, Lot Number: 22JBR391,22JBI641,22GBG964; e. NEURO PACK-LF, Item Number: DYNJ0038440B, Case UDI/GTIN: 40193489506885, Unit UDI/GTIN: 10193489506884, Lot Number: 22IME936; f. CUSTOM NEURO PACK-LF, Item Number: DYNJ0190156F, Case UDI/GTIN: 40193489357531, Unit UDI/GTIN: 10193489357530, Lot Number: 22JMA809; g. NEURO PACK-LF, Item Number: DYNJ0367094L, Case UDI/GTIN: 40889942123859, Unit UDI/GTIN: 10889942123858, Lot Number: 22IMI193,22HMF079; h. NEURO PACK-LF, Item Number: DYNJ0374024J, Case UDI/GTIN: 40889942902119, Unit UDI/GTIN: 10889942902118, Lot Number: 22HBW509,22HBX254,22HBV379; i. NEURO PACK-LF, Item Number: DYNJ04596K, Case UDI/GTIN: 40193489301343, Unit UDI/GTIN: 10193489301342, Lot Number: 22JMA062,22IMB264; j. NEURO PACK-LF, Item Number: DYNJ04671Q, Case UDI/GTIN: 40888277743312, Unit UDI/GTIN: 10888277743311, Lot Number: 22HMC512; k. NEURO/LAMINECTOMY BASIN PK-LF, Item Number: DYNJ0781823K, Case UDI/GTIN: 40193489919197, Unit UDI/GTIN: 10193489919196, Lot Number: 22JMB723,22HMD049; l. U H S NEURO PACK SC, Item Number: DYNJ07952J, Case UDI/GTIN: 40889942607953, Unit UDI/GTIN: 10889942607952, Lot Number: 22JBO711; m. NEURO PACK-CELEBRATION, Item Number: DYNJ14032, Case UDI/GTIN: 40080196777953, Unit UDI/GTIN: 10080196777952, Lot Number: 22KBB459,22IBU513; n. NEURO PACK, Item Number: DYNJ14077I, Case UDI/GTIN: 40193489927673, Unit UDI/GTIN: 10193489927672, Lot Number: 22JBJ480; o. NEURO BASIN PACK-LF, Item Number: DYNJ16473K, Case UDI/GTIN: 40193489920865, Unit UDI/GTIN: 10193489920864, Lot Number: 22JDC136,22HDC097; p. NEURO PACK, Item Number: DYNJ19847M, Case UDI/GTIN: 40888277792303, Unit UDI/GTIN: 10888277792302, Lot Number: 22JBY146,22JBK343; q. MAJOR NEURO PK-LF, Item Number: DYNJ21243M, Case UDI/GTIN: 40193489225236, Unit UDI/GTIN: 10193489225235, Lot Number: 22HBY346; r. NINOR NEURO PK-LF, Item Number: DYNJ21244N, Case UDI/GTIN: 40193489225229, Unit UDI/GTIN: 10193489225228, Lot Number: 22JBV649; s. NEURO VP SHUNT/VAGAL NERVE-RF, Item Number: DYNJ21925S, Case UDI/GTIN: 40195327105021, Unit UDI/GTIN: 10195327105020, Lot Number: 22IBS173; t. NEURO PACK-LF, Item Number: DYNJ25097F, Case UDI/GTIN: 40889942871576, Unit UDI/GTIN: 10889942871575, Lot Number: 22JBK228,22JBI289; u. NEURO PACK, Item Number: DYNJ30477K, Case UDI/GTIN: 40193489912679, Unit UDI/GTIN: 10193489912678, Lot Number: 22JMG210,22HMB824; v. CRANIOTOMY, Item Number: DYNJ35349C, Case UDI/GTIN: 40888277858061, Unit UDI/GTIN: 10888277858060, Lot Number: 22HBP277; w. PEDIATRIC NEURO PACK, Item Number: DYNJ35480F, Case UDI/GTIN: 40193489803694, Unit UDI/GTIN: 10193489803693, Lot Number: 22JMB626,22IMF848,22IMC064; x. NEURO MATRIX PACK, Item Number: DYNJ36594F, Case UDI/GTIN: 40193489928991, Unit UDI/GTIN: 10193489928990, Lot Number: 22JBF140,22IBG656,22HBM006; y. ACOUSTIC NEUROMA PACK-LF, Item Number: DYNJ37741B, Case UDI/GTIN: 40195327081332, Unit UDI/GTIN: 10195327081331, Lot Number: 22JMC172,22HMD563; z. MAJOR NEURO PACK-LF, Item Number: DYNJ37751B, Case UDI/GTIN: 40195327082209, Unit UDI/GTIN: 10195327082208, Lot Number: 22JMF991; aa. SCRIPPS SW NEURO PACK-LF, Item Number: DYNJ39836F, Case UDI/GTIN: 40195327176717, Unit UDI/GTIN: 10195327176716, Lot Number: 22JME760,22HMI113,22HMD278,22GMB860; bb. NEURO PACK, Item Number: DYNJ41225B, Case UDI/GTIN: 40193489675673, Unit UDI/GTIN: 10193489675672, Lot Number: 22JBX284; cc. GENERAL PACK, Item Number: DYNJ41249C, Case UDI/GTIN: 40888277882035, Unit UDI/GTIN: 10888277882034, Lot Number: 22IBG204; dd. NEURO PK, Item Number: DYNJ41276F, Case UDI/GTIN: 40195327204021, Unit UDI/GTIN: 10195327204020, Lot Number: 22JMG029,22HMD792; ee. NEURO PACK, Item Number: DYNJ41579A, Case UDI/GTIN: 40888277935274, Unit UDI/GTIN: 10888277935273, Lot Number: 22IBA883; ff. NEURO PACK, Item Number: DYNJ41633B, Case UDI/GTIN: 40888277934918, Unit UDI/GTIN: 10888277934917, Lot Number: 22IBU441,22HBX309,22HBP962; gg. NEURO PACK, Item Number: DYNJ42484, Case UDI/GTIN: 40884389924045, Unit UDI/GTIN: 10884389924044, Lot Number: 22IBH224; hh. NEURO PACK-LF, Item Number: DYNJ42844D, Case UDI/GTIN: 40193489880565, Unit UDI/GTIN: 10193489880564, Lot Number: 22JBT933,22HBZ336; ii. NEURO PACK, Item Number: DYNJ43177B, Case UDI/GTIN: 40889942884392, Unit UDI/GTIN: 10889942884391, Lot Number: 22IMC154; jj. NEURO PACK, Item Number: DYNJ43856C, Case UDI/GTIN: 40195327200238, Unit UDI/GTIN: 10195327200237, Lot Number: 22IBS432,22HBP196; kk. NEURO PACK, Item Number: DYNJ43934A, Case UDI/GTIN: 40193489733601, Unit UDI/GTIN: 10193489733600, Lot Number: 22IMD151; ll. NEURO PACK, Item Number: DYNJ44014B, Case UDI/GTIN: 40889942278917, Unit UDI/GTIN: 10889942278916, Lot Number: 22KMA329,22JMC591; mm. CRANIOTOMY PACK, Item Number: DYNJ44040, Case UDI/GTIN: 40888277085955, Unit UDI/GTIN: 10888277085954, Lot Number: 22HBV694; nn. PK, NEURO-MINOR, Item Number: DYNJ45053C, Case UDI/GTIN: 40195327248759, Unit UDI/GTIN: 10195327248758, Lot Number: 22IBT923; oo. NEURO PACK, Item Number: DYNJ45267B, Case UDI/GTIN: 40193489852425, Unit UDI/GTIN: 10193489852424, Lot Number: 22HBV288; pp. NEURO PACK, Item Number: DYNJ46232A, Case UDI/GTIN: 40889942153450, Unit UDI/GTIN: 10889942153459, Lot Number: 22JBW760; qq. NEURO PACK, Item Number: DYNJ46238C, Case UDI/GTIN: 40888277737304, Unit UDI/GTIN: 10888277737303, Lot Number: 22IBG653,22HBX977,22HBX980; rr. PK, NEURO-MINOR, Item Number: DYNJ46282A, Case UDI/GTIN: 40193489310475, Unit UDI/GTIN: 10193489310474, Lot Number: 22JBO162,22JBO223,22IBJ968; ss. NEURO BASIC, Item Number: DYNJ46424D, Case UDI/GTIN: 40193489710350, Unit UDI/GTIN: 10193489710359, Lot Number: 22IBD742; tt. NEURO BASIC, Item Number: DYNJ46424F, Case UDI/GTIN: 40195327260683, Unit UDI/GTIN: 10195327260682, Lot Number: 22JBB084; uu. CRANIOTOMY PACK (CRSJE)227-LF, Item Number: DYNJ47487A, Case UDI/GTIN: 40889942106241, Unit UDI/GTIN: 10889942106240, Lot Number: 22JMF056,22HMD080; vv. NEURO PACK, Item Number: DYNJ48765, Case UDI/GTIN: 40888277943491, Unit UDI/GTIN: 10888277943490, Lot Number: 22IBQ098,22IBE948,22HME671; ww. NEURO PACK, Item Number: DYNJ49004, Case UDI/GTIN: 40888277810809, Unit UDI/GTIN: 10888277810808, Lot Number: 22JMI090,22JMC180,22IMD860,22HMD361; xx. NEURO CRANI PACK, Item Number: DYNJ49358, Case UDI/GTIN: 40888277847096, Unit UDI/GTIN: 10888277847095, Lot Number: 22JBQ325; yy. NEURO PACK, Item Number: DYNJ49529B, Case UDI/GTIN: 40889942203780, Unit UDI/GTIN: 10889942203789, Lot Number: 22IBS439,22IBE973; zz. NEURO TRAY-LF, Item Number: DYNJ49580C, Case UDI/GTIN: 40193489231206, Unit UDI/GTIN: 10193489231205, Lot Number: 22IBN986; aaa. NEURO PACK, Item Number: DYNJ50292F, Case UDI/GTIN: 40193489834438, Unit UDI/GTIN: 10193489834437, Lot Number: 22JBV778,22JBC215; bbb. WH NEURO PACK, Item Number: DYNJ50569, Case UDI/GTIN: 40889942008453, Unit UDI/GTIN: 10889942008452, Lot Number: 22JBQ343; ccc. RFT ISC-N NEURO PACK, Item Number: DYNJ50852G, Case UDI/GTIN: 40193489565028, Unit UDI/GTIN: 10193489565027, Lot Number: 22JMA472,22HMD933; ddd. NEURO-LF, Item Number: DYNJ52055F, Case UDI/GTIN: 40195327096336, Unit UDI/GTIN: 10195327096335, Lot Number: 22IBD221; eee. NEURO PACK, Item Number: DYNJ52243B, Case UDI/GTIN: 40889942829294, Unit UDI/GTIN: 10889942829293, Lot Number: 22IMF259; fff. NEURO LUMBAR PACK, Item Number: DYNJ53664D, Case UDI/GTIN: 40193489232067, Unit UDI/GTIN: 10193489232066, Lot Number: 22IBH772; ggg. NEURO FUSION PACK-LF, Item Number: DYNJ54360C, Case UDI/GTIN: 40193489815451, Unit UDI/GTIN: 10193489815450, Lot Number: 22IBR798; hhh. NEURO CERVICAL PACK, Item Number: DYNJ55737A, Case UDI/GTIN: 40889942943266, Unit UDI/GTIN: 10889942943265, Lot Number: 22JMB645; iii. NEURO PACK, Item Number: DYNJ57663, Case UDI/GTIN: 40889942763840, Unit UDI/GTIN: 10889942763849, Lot Number: 22JBW468,22IBB120; jjj. VP SHUNT PACK, Item Number: DYNJ59702F, Case UDI/GTIN: 40195327200269, Unit UDI/GTIN: 10195327200268, Lot Number: 22JBM510; kkk. NEURO BASIC PACK, Item Number: DYNJ60054, Case UDI/GTIN: 40888277797988, Unit UDI/GTIN: 10888277797987, Lot Number: 22KBA488,22JBR179,22IBI219; lll. NEURO PACK, Item Number: DYNJ60792C, Case UDI/GTIN: 40195327126965, Unit UDI/GTIN: 10195327126964, Lot Number: 22HBN525; mmm. CHRISTUS CHILDRENS NEURO PK, Item Number: DYNJ61168B, Case UDI/GTIN: 40195327118946, Unit UDI/GTIN: 10195327118945, Lot Number: 22IBR244,22HBY116,22HBV048; nnn. CHRISTUS CHILDRENS VP SHUNT PK, Item Number: DYNJ61174B, Case UDI/GTIN: 40195327119486, Unit UDI/GTIN: 10195327119485, Lot Number: 22JLA318,22ILA429,22HLB020; ooo. RF NEURO-SHUNT PACK, Item Number: DYNJ61387A, Case UDI/GTIN: 40193489444149, Unit UDI/GTIN: 10193489444148, Lot Number: 22IMG094,22IMG100; ppp. NEURO PACK, Item Number: DYNJ61419A, Case UDI/GTIN: 40193489676366, Unit UDI/GTIN: 10193489676365, Lot Number: 22JMH617; qqq. NEURO PACK, Item Number: DYNJ61740F, Case UDI/GTIN: 40195327238811, Unit UDI/GTIN: 10195327238810, Lot Number: 22IBF063; rrr. NEURO ST DAVIDS MEDICAL CTR, Item Number: DYNJ61998, Case UDI/GTIN: 40193489615013, Unit UDI/GTIN: 10193489615012, Lot Number: 22IBF340,22HBX978,22HBX979; sss. GIO NEURO PACK, Item Number: DYNJ62652A, Case UDI/GTIN: 40193489224581, Unit UDI/GTIN: 10193489224580, Lot Number: 22IBK347; ttt. NEURO KIT, Item Number: DYNJ62854C, Case UDI/GTIN: 40193489426985, Unit UDI/GTIN: 10193489426984, Lot Number: 22IBU624; uuu. DISCECTOMY PACK, Item Number: DYNJ67835, Case UDI/GTIN: 40193489444811, Unit UDI/GTIN: 10193489444810, Lot Number: 22IBV281; vvv. NEURO PACK, Item Number: DYNJ68898C, Case UDI/GTIN: 40195327060283, Unit UDI/GTIN: 10195327060282, Lot Number: 22IMI313; www. BASIC NEURO PACK-LF, Item Number: DYNJ81867, Case UDI/GTIN: 40195327153305, Unit UDI/GTIN: 10195327153304, Lot Number: 22HMC380,22HMB884; xxx. NEURO PACK, Item Number: DYNJ82633, Case UDI/GTIN: 40195327199556, Unit UDI/GTIN: 10195327199555, Lot Number: 22HBM512; yyy. NEURO PACK, Item Number: DYNJ83029, Case UDI/GTIN: 40195327228980, Unit UDI/GTIN: 10195327228989, Lot Number: 22JBV413; zzz. NEURO, Item Number: DYNJ900904J, Case UDI/GTIN: 40193489906616, Unit UDI/GTIN: 10193489906615, Lot Number: 22JBY355,22KBC323; aaaa. NEURO, Item Number: DYNJ901680G, Case UDI/GTIN: 40193489308083, Unit UDI/GTIN: 10193489308082, Lot Number: 22KBA252,22JBE473; bbbb. FHCW NEURO PACK, Item Number: DYNJ901990C, Case UDI/GTIN: 40193489932363, Unit UDI/GTIN: 10193489932362, Lot Number: 22JBL441,22IBV599; cccc. NEURO FERREE, Item Number: DYNJ902388K, Case UDI/GTIN: 40195327224753, Unit UDI/GTIN: 10195327224752, Lot Number: 22IBS547; dddd. NEURO, Item Number: DYNJ902585A, Case UDI/GTIN: 40193489985413, Unit UDI/GTIN: 10193489985412, Lot Number: 22IDA639; eeee. NEURO PACK CW, Item Number: DYNJ903091B, Case UDI/GTIN: 40193489961530, Unit UDI/GTIN: 10193489961539, Lot Number: 22IBU575,22IBU579; ffff. NEURO, Item Number: DYNJ903519A, Case UDI/GTIN: 40889942594215, Unit UDI/GTIN: 10889942594214, Lot Number: 22JBU552; gggg. FHT NEURO, Item Number: DYNJ903566C, Case UDI/GTIN: 40193489932103, Unit UDI/GTIN: 10193489932102, Lot Number: 22JBB451; hhhh. NEURO BASIC, Item Number: DYNJ904052G, Case UDI/GTIN: 40195327220922, Unit UDI/GTIN: 10195327220921, Lot Number: 22KDA580,22KDA234; iiii. NEURO LUMBAR, Item Number: DYNJ904111I, Case UDI/GTIN: 40193489363518, Unit UDI/GTIN: 10193489363517, Lot Number: 22IBO732,22IBN438,22IBA887; jjjj. NCH NEURO, Item Number: DYNJ904797B, Case UDI/GTIN: 40195327037988, Unit UDI/GTIN: 10195327037987, Lot Number: 22IBF188; kkkk. TAVI, Item Number: DYNJ904981C, Case UDI/GTIN: 40193489475136, Unit UDI/GTIN: 10193489475135, Lot Number: 22JBV630,22JBB134; llll. CHN OR NEURO, Item Number: DYNJ907876A, Case UDI/GTIN: 40195327011117, Unit UDI/GTIN: 10195327011116, Lot Number: 22HBR766; mmmm. NEURO PACK-LF, Item Number: DYNJC9302F, Case UDI/GTIN: 40195327032754, Unit UDI/GTIN: 10195327032753, Lot Number: 22JMB483; nnnn. NEURO-CRANI-LF, Item Number: DYNJS1001A, Case UDI/GTIN: 40080196665373, Unit UDI/GTIN: 10080196665372, Lot Number: 22IBS931,22HBX420

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 30 of 38

Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II

Z-1089-2023
Recall number
Z-1089-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
194 cases (508 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. GYN LAPAROTOMY HARPER PACK-LF, Item Number: DYNJ0160684D, Case UDI/GTIN: 40193489205528, Unit UDI/GTIN: 10193489205527, Lot Number: 22JDA531,22IDB178,22IDA705; b. OB GYN LAP PACK-LF, Item Number: DYNJ43413C, Case UDI/GTIN: 40193489901185, Unit UDI/GTIN: 10193489901184, Lot Number: 22JBS296; c. VAGINAL HYSTERECTOMY PACK, Item Number: DYNJ47624B, Case UDI/GTIN: 40193489735360, Unit UDI/GTIN: 10193489735369, Lot Number: 22KBB429,22IBE503; d. DELTA PACK, Item Number: DYNJ59117A, Case UDI/GTIN: 40193489457897, Unit UDI/GTIN: 10193489457896, Lot Number: 22JMC869,22JMC852,22HMD762; e. MAJOR VAGINAL-LF, Item Number: DYNJ901807G, Case UDI/GTIN: 40193489814157, Unit UDI/GTIN: 10193489814156, Lot Number: 22IDC043; f. GYN LAPAROSCOPY II, Item Number: DYNJS2030D, Case UDI/GTIN: 40193489214148, Unit UDI/GTIN: 10193489214147, Lot Number: 22JDA984;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 31 of 38

Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY

Z-1090-2023
Recall number
Z-1090-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
109 cases (316 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. PELVISCOPY PACK, Item Number: DYNJ82555, Case UDI/GTIN: 40195327198252, Unit UDI/GTIN: 10195327198251, Lot Number: 22HBQ035; b. D-PELVISCOPY, Item Number: DYNJ900628I, Case UDI/GTIN: 40195327224142, Unit UDI/GTIN: 10195327224141, Lot Number: 22JDB340;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 32 of 38

Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE'S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF

Z-1091-2023
Recall number
Z-1091-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
8,064 cases (12,425 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. GYN-URO LAPSCP CDS-LF, Item Number: CDS981583U, Case UDI/GTIN: 40195327209767, Unit UDI/GTIN: 10195327209766, Lot Number: 22JBE255; b. ROBOTIC CDS, Item Number: CDS981882W, Case UDI/GTIN: 40195327144983, Unit UDI/GTIN: 10195327144982, Lot Number: 22IBR176; c. GYN LAPAROSCOPY CDS-LF, Item Number: CDS981988I, Case UDI/GTIN: 40193489744164, Unit UDI/GTIN: 10193489744163, Lot Number: 22KBF564,22JBV989; d. GYN LAPAROSCOPY, Item Number: CDS982032Y, Case UDI/GTIN: 40195327248858, Unit UDI/GTIN: 10195327248857, Lot Number: 22JBE743; e. GYN LAPAROSCOPY CDS, Item Number: CDS982371G, Case UDI/GTIN: 40193489209397, Unit UDI/GTIN: 10193489209396, Lot Number: 22JBU375,22JBU054; f. UNIVERSAL ROBOTIC ORLANDO, Item Number: CDS982857K, Case UDI/GTIN: 40193489927864, Unit UDI/GTIN: 10193489927863, Lot Number: 22IBA586; g. GYN ROBOTIC CDS, Item Number: CDS982888M, Case UDI/GTIN: 40195327110698, Unit UDI/GTIN: 10195327110697, Lot Number: 22JBK498; h. GYN LAPAROSCOPY CDS-1, Item Number: CDS982892F, Case UDI/GTIN: 40889942216926, Unit UDI/GTIN: 10889942216925, Lot Number: 22JBI848; i. CUH GYN LAPAROSCOPY CDS, Item Number: CDS983206L, Case UDI/GTIN: 40195327164592, Unit UDI/GTIN: 10195327164591, Lot Number: 22JBM358; j. CUH GEN/GYN ROBOTIC CDS, Item Number: CDS983375L, Case UDI/GTIN: 40195327164547, Unit UDI/GTIN: 10195327164546, Lot Number: 22JBI299; k. LAVH CDS-LF, Item Number: CDS983868F, Case UDI/GTIN: 40889942017233, Unit UDI/GTIN: 10889942017232, Lot Number: 22JDB254; l. GYN LAPAROSCOPY CDS-LF, Item Number: CDS984536J, Case UDI/GTIN: 40193489831345, Unit UDI/GTIN: 10193489831344, Lot Number: 22IDB843; m. GYN LAPAROSCOPY CDS UCC-LF, Item Number: CDS984684D, Case UDI/GTIN: 40193489571364, Unit UDI/GTIN: 10193489571363, Lot Number: 22JBR850,22JBE881,22IBV318; n. DAY SURG GYN LAP CDS, Item Number: CDS984996K, Case UDI/GTIN: 40195327175772, Unit UDI/GTIN: 10195327175771, Lot Number: 22JBD508; o. GYN LAPAROSCOPY CDS, Item Number: CDS985217J, Case UDI/GTIN: 40195327110841, Unit UDI/GTIN: 10195327110840, Lot Number: 22KBC728,22IBA646; p. DAVINCI HYSTERECTOMY CDS, Item Number: CDS985344D, Case UDI/GTIN: 40193489905527, Unit UDI/GTIN: 10193489905526, Lot Number: 22IBR928,22IBS195; q. GYN LAP/ROBOTIC, Item Number: CDS985466G, Case UDI/GTIN: 40195327043118, Unit UDI/GTIN: 10195327043117, Lot Number: 22JDB080; r. DAVINCI PACK-LF, Item Number: DYNJ0046535D, Case UDI/GTIN: 40195327095667, Unit UDI/GTIN: 10195327095666, Lot Number: 22JMH534; s. DAVINCI PACK-LF, Item Number: DYNJ0161960F, Case UDI/GTIN: 40195327171521, Unit UDI/GTIN: 10195327171520, Lot Number: 22IDB492,22IDA146; t. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ01910K, Case UDI/GTIN: 40193489962803, Unit UDI/GTIN: 10193489962802, Lot Number: 22IBU972; u. ROBOTIC PACK, Item Number: DYNJ02457K, Case UDI/GTIN: 40195327108923, Unit UDI/GTIN: 10195327108922, Lot Number: 22JMG295; v. GYN LAP - UNIV, Item Number: DYNJ0375503L, Case UDI/GTIN: 40193489943215, Unit UDI/GTIN: 10193489943214, Lot Number: 22JBP432; w. BASIC LAVH PACK, Item Number: DYNJ0378714G, Case UDI/GTIN: 40889942435266, Unit UDI/GTIN: 10889942435265, Lot Number: 22IBI287; x. GYN/LAPAROSCOPY PACK-LF, Item Number: DYNJ0395118K, Case UDI/GTIN: 40195327063895, Unit UDI/GTIN: 10195327063894, Lot Number: 22JBS258; y. LAPAROSCOPIC GYN PACK-LF, Item Number: DYNJ04718T, Case UDI/GTIN: 40193489444873, Unit UDI/GTIN: 10193489444872, Lot Number: 22JMC979; z. DAVINCI PACK-LF, Item Number: DYNJ0556546D, Case UDI/GTIN: 40195327271726, Unit UDI/GTIN: 10195327271725, Lot Number: 22JMI211; aa. SCC GYN LAPAROSCOPY PACK, Item Number: DYNJ16604R, Case UDI/GTIN: 40195327218615, Unit UDI/GTIN: 10195327218614, Lot Number: 22JMB584; bb. URO GYN PACK-LF, Item Number: DYNJ17454M, Case UDI/GTIN: 40193489776028, Unit UDI/GTIN: 10193489776027, Lot Number: 22IBN968,22HBK091; cc. GYN LAPAROSCOPY PACK, Item Number: DYNJ30301D, Case UDI/GTIN: 40889942764953, Unit UDI/GTIN: 10889942764952, Lot Number: 22JBX986; dd. TUBAL PACK, Item Number: DYNJ30481G, Case UDI/GTIN: 40193489912891, Unit UDI/GTIN: 10193489912890, Lot Number: 22JMA315; ee. GYN LAP PACK-LF, Item Number: DYNJ32754M, Case UDI/GTIN: 40193489588980, Unit UDI/GTIN: 10193489588989, Lot Number: 22IMD300,22IMD302; ff. LAVH PACK, Item Number: DYNJ36508B, Case UDI/GTIN: 40889942715764, Unit UDI/GTIN: 10889942715763, Lot Number: 22JBJ622; gg. GYN LAPAROSCOPY-LF, Item Number: DYNJ36713B, Case UDI/GTIN: 40195327148035, Unit UDI/GTIN: 10195327148034, Lot Number: 22JBG940,22HBR656; hh. LAVH PACK, Item Number: DYNJ37785B, Case UDI/GTIN: 40888277792280, Unit UDI/GTIN: 10888277792289, Lot Number: 22IBK833; ii. PK-GYN-LAPAROSCOPY, Item Number: DYNJ42386D, Case UDI/GTIN: 40195327253340, Unit UDI/GTIN: 10195327253349, Lot Number: 22JMH924; jj. MAJOR LAP PACK 2-LF, Item Number: DYNJ42635D, Case UDI/GTIN: 40193489919425, Unit UDI/GTIN: 10193489919424, Lot Number: 22JBW532,22JBH135,22IBD371; kk. TUBAL PACK, Item Number: DYNJ42636, Case UDI/GTIN: 40888277003577, Unit UDI/GTIN: 10888277003576, Lot Number: 22KBA571; ll. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ42838B, Case UDI/GTIN: 40193489880374, Unit UDI/GTIN: 10193489880373, Lot Number: 22IBT573,22HBY144; mm. PK, ROBOTICS-GYN, Item Number: DYNJ43715B, Case UDI/GTIN: 40193489322911, Unit UDI/GTIN: 10193489322910, Lot Number: 22IBU770; nn. SVMMC GEN ROBOTIC PACK, Item Number: DYNJ43770L, Case UDI/GTIN: 40193489989992, Unit UDI/GTIN: 10193489989991, Lot Number: 22JBT938,22IBC524; oo. SVMMC GYN ROBOTIC PACK, Item Number: DYNJ43782K, Case UDI/GTIN: 40193489989893, Unit UDI/GTIN: 10193489989892, Lot Number: 22JBM498,22IBD372; pp. PACK, GYN-D&C, Item Number: DYNJ43931C, Case UDI/GTIN: 40193489431606, Unit UDI/GTIN: 10193489431605, Lot Number: 22JMD510; qq. DA VINCI PROSTATE/COLPOPEXY, Item Number: DYNJ44864S, Case UDI/GTIN: 40195327127627, Unit UDI/GTIN: 10195327127626, Lot Number: 22HBY159; rr. ROBOT PACK, Item Number: DYNJ45184F, Case UDI/GTIN: 40195327191475, Unit UDI/GTIN: 10195327191474, Lot Number: 22JBD483; ss. PK, GYN-LAPAROSCOPY, Item Number: DYNJ46271A, Case UDI/GTIN: 40193489338295, Unit UDI/GTIN: 10193489338294, Lot Number: 22IBS007; tt. LAPAROSCOPIC GYN PACK, Item Number: DYNJ47274L, Case UDI/GTIN: 40195327263943, Unit UDI/GTIN: 10195327263942, Lot Number: 22JMI249,22JMA188; uu. DAVINCI PACK-RFD, Item Number: DYNJ47762M, Case UDI/GTIN: 40195327105434, Unit UDI/GTIN: 10195327105433, Lot Number: 22JME004,22JMD998; vv. GYN ROBOTIC PACK, Item Number: DYNJ47766Q, Case UDI/GTIN: 40195327270002, Unit UDI/GTIN: 10195327270001, Lot Number: 22JDB952; ww. LAVH PACK, Item Number: DYNJ48599, Case UDI/GTIN: 40888277915115, Unit UDI/GTIN: 10888277915114, Lot Number: 22JBC120; xx. ST. ANNE'S MULTI PORT PACK, Item Number: DYNJ48638G, Case UDI/GTIN: 40195327109159, Unit UDI/GTIN: 10195327109158, Lot Number: 22IBP249; yy. LAVH PACK, Item Number: DYNJ49353, Case UDI/GTIN: 40888277846761, Unit UDI/GTIN: 10888277846760, Lot Number: 22IBN984; zz. SOUTH SC RFT GYN LAP PACK, Item Number: DYNJ50840A, Case UDI/GTIN: 40889942221371, Unit UDI/GTIN: 10889942221370, Lot Number: 22JMI259,22JMC606; aaa. GYN LAPAROSCOPY PACK, Item Number: DYNJ51102B, Case UDI/GTIN: 40193489985338, Unit UDI/GTIN: 10193489985337, Lot Number: 22JDB774; bbb. LITHOTOMY PENILE PACK, Item Number: DYNJ51161C, Case UDI/GTIN: 40889942493792, Unit UDI/GTIN: 10889942493791, Lot Number: 22JBH136,22HBR181; ccc. DAVINCI GENERAL PACK, Item Number: DYNJ51399J, Case UDI/GTIN: 40193489984492, Unit UDI/GTIN: 10193489984491, Lot Number: 22HDA632; ddd. DAVINCI GYN PACK, Item Number: DYNJ51400J, Case UDI/GTIN: 40193489984508, Unit UDI/GTIN: 10193489984507, Lot Number: 22IDA309; eee. DAVINCI GYN PACK, Item Number: DYNJ51400K, Case UDI/GTIN: 40195327277605, Unit UDI/GTIN: 10195327277604, Lot Number: 22JDB871; fff. ROBOTIC PROSTATE PACK, Item Number: DYNJ52085M, Case UDI/GTIN: 40195327210374, Unit UDI/GTIN: 10195327210373, Lot Number: 22JDB086; ggg. GYN ROBOTIC PACK-LF, Item Number: DYNJ52432J, Case UDI/GTIN: 40195327073979, Unit UDI/GTIN: 10195327073978, Lot Number: 22JDB177; hhh. SCRIPPS SW ROBOTIC PACK, Item Number: DYNJ52564D, Case UDI/GTIN: 40195327176427, Unit UDI/GTIN: 10195327176426, Lot Number: 22HMF120,22HME681,22HME682,22FMB534; iii. GYN LITHOTOMY PACK, Item Number: DYNJ53327A, Case UDI/GTIN: 40889942592938, Unit UDI/GTIN: 10889942592937, Lot Number: 22JMG479; jjj. GYN LAPAROSCOPY PACK, Item Number: DYNJ53631G, Case UDI/GTIN: 40195327145430, Unit UDI/GTIN: 10195327145439, Lot Number: 22IBT104; kkk. DEACONESS PELVIC LAP PACK, Item Number: DYNJ53820A, Case UDI/GTIN: 40195327132188, Unit UDI/GTIN: 10195327132187, Lot Number: 22IBL549; lll. WOMENS ROBOT PACK, Item Number: DYNJ53857A, Case UDI/GTIN: 40193489497664, Unit UDI/GTIN: 10193489497663, Lot Number: 22IBD203; mmm. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ54367, Case UDI/GTIN: 40889942478881, Unit UDI/GTIN: 10889942478880, Lot Number: 22JMG368; nnn. MAJOR GYN PACK, Item Number: DYNJ55693I, Case UDI/GTIN: 40193489847575, Unit UDI/GTIN: 10193489847574, Lot Number: 22IBL365; ooo. GYN LAPAROSCOPY PACK, Item Number: DYNJ56441, Case UDI/GTIN: 40889942646426, Unit UDI/GTIN: 10889942646425, Lot Number: 22HBH543; ppp. TUBAL PACK-LF, Item Number: DYNJ56657, Case UDI/GTIN: 40889942666271, Unit UDI/GTIN: 10889942666270, Lot Number: 22IMB764; qqq. PK, GYN-LAPAROSCOPY, Item Number: DYNJ57609B, Case UDI/GTIN: 40195327244577, Unit UDI/GTIN: 10195327244576, Lot Number: 22IMI129; rrr. LAVH PACK, Item Number: DYNJ57740, Case UDI/GTIN: 40889942773689, Unit UDI/GTIN: 10889942773688, Lot Number: 22IBL578; sss. LAPAROTOMY PACK, Item Number: DYNJ59079D, Case UDI/GTIN: 40195327200252, Unit UDI/GTIN: 10195327200251, Lot Number: 22JBC271,22HBF903; ttt. URO/GEN ROBOTIC PACK, Item Number: DYNJ60803J, Case UDI/GTIN: 40195327138821, Unit UDI/GTIN: 10195327138820, Lot Number: 22KDA153,22IDA962; uuu. BASIC ROBOTIC PACK, Item Number: DYNJ62750B, Case UDI/GTIN: 40193489975858, Unit UDI/GTIN: 10193489975857, Lot Number: 22KBC719,22HBV643,22HBI644; vvv. LAPAROSCOPIC GYN PACK, Item Number: DYNJ62831B, Case UDI/GTIN: 40193489887274, Unit UDI/GTIN: 10193489887273, Lot Number: 22JDC183; www. PK, ROBOTICS-GYN, Item Number: DYNJ63445B, Case UDI/GTIN: 40193489318396, Unit UDI/GTIN: 10193489318395, Lot Number: 22JBC766,22IBI894; xxx. PQ CHG CTRY GYN LAP PK, Item Number: DYNJ64039A, Case UDI/GTIN: 40195327263585, Unit UDI/GTIN: 10195327263584, Lot Number: 22JMC821; yyy. GYN DAVINCI PACK, Item Number: DYNJ64266, Case UDI/GTIN: 40193489795517, Unit UDI/GTIN: 10193489795516, Lot Number: 22JDB068; zzz. ROBOT GYN SHARED, Item Number: DYNJ64793B, Case UDI/GTIN: 40195327217915, Unit UDI/GTIN: 10195327217914, Lot Number: 22JDA845,22HDC106; aaaa. PK, ROBOTICS-GEN, Item Number: DYNJ65193A, Case UDI/GTIN: 40195327244584, Unit UDI/GTIN: 10195327244583, Lot Number: 22IMH017; bbbb. DAVINCI PACK, Item Number: DYNJ66298D, Case UDI/GTIN: 40195327095896, Unit UDI/GTIN: 10195327095895, Lot Number: 22JBQ463; cccc. ROBOTIC GYN PACK, Item Number: DYNJ68688A, Case UDI/GTIN: 40195327095872, Unit UDI/GTIN: 10195327095871, Lot Number: 22JBK548; dddd. ROBOTICS PACK, Item Number: DYNJ69869, Case UDI/GTIN: 40193489992244, Unit UDI/GTIN: 10193489992243, Lot Number: 22HBY203; eeee. PK- ROBOTICS, Item Number: DYNJ69869A, Case UDI/GTIN: 40195327252558, Unit UDI/GTIN: 10195327252557, Lot Number: 22JBL867; ffff. GYN LAPAROSCOPY, Item Number: DYNJ69893A, Case UDI/GTIN: 40195327235018, Unit UDI/GTIN: 10195327235017, Lot Number: 22JBC621,22IBI272; gggg. GU ROBOTIC PACK, Item Number: DYNJ82464, Case UDI/GTIN: 40195327197187, Unit UDI/GTIN: 10195327197186, Lot Number: 22HBJ903; hhhh. GYN PACK, Item Number: DYNJ82488, Case UDI/GTIN: 40195327197446, Unit UDI/GTIN: 10195327197445, Lot Number: 22HBJ906; iiii. BASIC GYN PACK, Item Number: DYNJ82505, Case UDI/GTIN: 40195327198306, Unit UDI/GTIN: 10195327198305, Lot Number: 22HBI366; jjjj. BWH GYN ROBOTICS PACK, Item Number: DYNJ82559, Case UDI/GTIN: 40195327197958, Unit UDI/GTIN: 10195327197957, Lot Number: 22HBQ038; kkkk. BWH GU ROBOTICS PACK, Item Number: DYNJ82560, Case UDI/GTIN: 40195327197965, Unit UDI/GTIN: 10195327197964, Lot Number: 22HBQ039; llll. URO GYN PACK, Item Number: DYNJ82621, Case UDI/GTIN: 40195327199075, Unit UDI/GTIN: 10195327199074, Lot Number: 22HBT063; mmmm. GYN LAP PACK, Item Number: DYNJ82624, Case UDI/GTIN: 40195327199105, Unit UDI/GTIN: 10195327199104, Lot Number: 22HBN265; nnnn. GYN LAPAROSCOPY, Item Number: DYNJ900262, Case UDI/GTIN: 40888277206473, Unit UDI/GTIN: 10888277206472, Lot Number: 22JBR395,22IBT179; oooo. ROBOTIC, Item Number: DYNJ900524K, Case UDI/GTIN: 40193489995290, Unit UDI/GTIN: 10193489995299, Lot Number: 22JDB906,22IDA179; pppp. GYN ROBOTIC, Item Number: DYNJ901046G, Case UDI/GTIN: 40193489820967, Unit UDI/GTIN: 10193489820966, Lot Number: 22JBW050; qqqq. CV ROBOTIC SET UP, Item Number: DYNJ901082C, Case UDI/GTIN: 40193489927659, Unit UDI/GTIN: 10193489927658, Lot Number: 22JBD190,22IBV320; rrrr. GYN LAPAROSCOPY, Item Number: DYNJ901208C, Case UDI/GTIN: 40193489313636, Unit UDI/GTIN: 10193489313635, Lot Number: 22KBF260; ssss. ROBOTIC LAVH, Item Number: DYNJ901281F, Case UDI/GTIN: 40193489961158, Unit UDI/GTIN: 10193489961157, Lot Number: 22IBQ970; tttt. ROBOTIC LAP CHOLE, Item Number: DYNJ901282I, Case UDI/GTIN: 40193489961165, Unit UDI/GTIN: 10193489961164, Lot Number: 22JBI004,22IBT626; uuuu. GYN LAPAROSCOPY, Item Number: DYNJ901370J, Case UDI/GTIN: 40195327245451, Unit UDI/GTIN: 10195327245450, Lot Number: 22JBR464; vvvv. GYN LAPAROSCOPY, Item Number: DYNJ901774F, Case UDI/GTIN: 40193489945677, Unit UDI/GTIN: 10193489945676, Lot Number: 22JBX890,22JBA940; wwww. GYN ROBOTIC, Item Number: DYNJ901796K, Case UDI/GTIN: 40193489979702, Unit UDI/GTIN: 10193489979701, Lot Number: 22IBD418; xxxx. GYN ENDOSCOPY-LF, Item Number: DYNJ901812J, Case UDI/GTIN: 40193489814164, Unit UDI/GTIN: 10193489814163, Lot Number: 22JDB621,22JDA090; yyyy. GYN LAPAROSCOPY, Item Number: DYNJ902371I, Case UDI/GTIN: 40195327223459, Unit UDI/GTIN: 10195327223458, Lot Number: 22KBH351; zzzz. LAP ROBOTIC, Item Number: DYNJ902384J, Case UDI/GTIN: 40193489978088, Unit UDI/GTIN: 10193489978087, Lot Number: 22JBD080; aaaaa. TUBAL LIGATION CDS, Item Number: DYNJ902721D, Case UDI/GTIN: 40193489907927, Unit UDI/GTIN: 10193489907926, Lot Number: 22JBW509; bbbbb. GYN LAPAROSCOPY, Item Number: DYNJ903422F, Case UDI/GTIN: 40193489700320, Unit UDI/GTIN: 10193489700329, Lot Number: 22KBF386,22JBN707; ccccc. ROBOTIC GYN & GU, Item Number: DYNJ903459F, Case UDI/GTIN: 40195327200375, Unit UDI/GTIN: 10195327200374, Lot Number: 22IBD806,22IBE664; ddddd. ROBOTIC, Item Number: DYNJ903485G, Case UDI/GTIN: 40195327172528, Unit UDI/GTIN: 10195327172527, Lot Number: 22JDB549; eeeee. GYN LAPAROSCOPY, Item Number: DYNJ903812C, Case UDI/GTIN: 40193489274111, Unit UDI/GTIN: 10193489274110, Lot Number: 22JBH771,22JBH772; fffff. ROBOT GYN, Item Number: DYNJ904709F, Case UDI/GTIN: 40195327159963, Unit UDI/GTIN: 10195327159962, Lot Number: 22JBW052; ggggg. GYN LAPAROSCOPY, Item Number: DYNJ904713A, Case UDI/GTIN: 40193489674300, Unit UDI/GTIN: 10193489674309, Lot Number: 22JBX929,22JBE278; hhhhh. FHWC ROBOTIC, Item Number: DYNJ905195F, Case UDI/GTIN: 40195327216482, Unit UDI/GTIN: 10195327216481, Lot Number: 22IBQ982; iiiii. GYN LAPAROSCOPY, Item Number: DYNJ905797B, Case UDI/GTIN: 40193489800815, Unit UDI/GTIN: 10193489800814, Lot Number: 22JMC890; jjjjj. GYN LAPAROSCOPY, Item Number: DYNJ906120C, Case UDI/GTIN: 40195327223701, Unit UDI/GTIN: 10195327223700, Lot Number: 22JDB406; kkkkk. ROBOTIC, Item Number: DYNJ906508B, Case UDI/GTIN: 40195327026524, Unit UDI/GTIN: 10195327026523, Lot Number: 22JMD368; lllll. PELVISCOPY, Item Number: DYNJ906536A, Case UDI/GTIN: 40193489815055, Unit UDI/GTIN: 10193489815054, Lot Number: 22KBB847,22KBA201; mmmmm. GENERAL ROBOT-TCN, Item Number: DYNJ906552D, Case UDI/GTIN: 40195327144860, Unit UDI/GTIN: 10195327144869, Lot Number: 22KBH170,22IBU705,22IBA547; nnnnn. ROBOTICS, Item Number: DYNJ906683B, Case UDI/GTIN: 40195327225705, Unit UDI/GTIN: 10195327225704, Lot Number: 22JBR762; ooooo. CVOR ROBOT, Item Number: DYNJ906692A, Case UDI/GTIN: 40195327061532, Unit UDI/GTIN: 10195327061531, Lot Number: 22IBT518; ppppp. GU-GEN ROBOTIC, Item Number: DYNJ906876C, Case UDI/GTIN: 40195327110681, Unit UDI/GTIN: 10195327110680, Lot Number: 22JBD052,22JBB138; qqqqq. FLOYD LAP GYN, Item Number: DYNJ906931C, Case UDI/GTIN: 40193489921299, Unit UDI/GTIN: 10193489921298, Lot Number: 22KBE721,22KBB791,22JBA952; rrrrr. GYN ROBOTIC, Item Number: DYNJ907492D, Case UDI/GTIN: 40195327247462, Unit UDI/GTIN: 10195327247461, Lot Number: 22JBA125; sssss. GYN LAPAROSCOPY CDS, Item Number: DYNJ907841A, Case UDI/GTIN: 40195327018321, Unit UDI/GTIN: 10195327018320, Lot Number: 22JBO683; ttttt. LAP TUBAL, Item Number: DYNJ907883A, Case UDI/GTIN: 40195327019151, Unit UDI/GTIN: 10195327019150, Lot Number: 22KBH354,22JBO108; uuuuu. DAVINCI GENERAL, Item Number: DYNJ908477A, Case UDI/GTIN: 40195327191925, Unit UDI/GTIN: 10195327191924, Lot Number: 22JMG912,22JMF336; vvvvv. DAVINCI LOW ANTERIOR RESECTION, Item Number: DYNJ908479A, Case UDI/GTIN: 40195327192021, Unit UDI/GTIN: 10195327192020, Lot Number: 22JBQ504; wwwww. GYN, Item Number: DYNJ908504A, Case UDI/GTIN: 40195327251292, Unit UDI/GTIN: 10195327251291, Lot Number: 22JBR467,22JBR815; xxxxx. PELVISCOPY PACK, Item Number: DYNJT2136M, Case UDI/GTIN: 40195327109067, Unit UDI/GTIN: 10195327109066, Lot Number: 22IME712; yyyyy. GYN LAPAROSCOPY STD PACK-LF, Item Number: PHS38678001B, Case UDI/GTIN: 40193489636612, Unit UDI/GTIN: 10193489636611, Lot Number: 22HBX127; zzzzz. LAP GYN PACK-LF, Item Number: PHS988229I, Case UDI/GTIN: 40193489766036, Unit UDI/GTIN: 10193489766035, Lot Number: 22JMG416,22IME802

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 33 of 38

Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-SECTION m. C-SECTION CDS n. C-SECTION PACK-LF o. C-SECTION PACK-LF p. C-SECTION PACK-LF q. C-SECTION PACK-LF r. C-BIRTH PACK-LF s. C SECTION PACK-LF t. C-SECTION PACK-LF u. C SECTION PACK-LF v. C-SECTION PACK-LF w. C SECTION PACK-LF x. C-SECTION PACK-LF y. C-SECTION PACK z. C-SECTION PACK-LF aa. C-SECTION PACK-LF bb. C-SECTION PACK-LF cc. C-SECTION PACK-LF dd. C-BIRTH SETUP PACK-LF ee. C-SECTION PACK-LF ff. C-SECTION PACK-LF gg. C-SECTION PACK-LF hh. C SECTION PACK-LF ii. C-SECTION PACK-LF jj. C-SECTION TRAY kk. C-SECTION PACK ll. C-SECTION PACK-LF mm. C-SECTION PACK nn. C-SECTION PACK oo. C-SECTION pp. C-SECTION PACK qq. SVMMC C-SECTION PACK rr. C-SECTION PACK-LF ss. C-SECTION SETUP PACK tt. C-SECTION PACK uu. C-SECTION PACK vv. C-SECTION PACK *STANDARD* ww. C-SECTION PACK xx. C-SECTION PACK yy. C-SECTION PACK zz. C-SECTION 83305, MERCY REG aaa. CUH C-SECTION PACK-LF bbb. C-SECTION PACK-LF ccc. C-SECTION PACK ddd. C-SECTION PACK eee. C-SECTION PACK fff. C-SECTION PK ggg. C-SECTION hhh. C-SECTION PACK iii. ST JO WEST C-SECTION BASIN-LF jjj. C SECTION PACK kkk. C-SECTION PACK lll. C SECTION PACK mmm. C SECTION DELIVERY nnn. C-SECTION PACK ooo. C-SECTION PACK ppp. C SECTION qqq. WR C SECTION PACK-LF rrr. C-SECTION PACK sss. PK, L&D-C SECTION ttt. C-SECTION PACK HIGHLAND-LF uuu. C- SECTION vvv. C SECTION PACK-LF www. C-SECTION PACK xxx. C-SECTION PACK yyy. C SECTION PACK zzz. PK, L&D-C SECTION aaaa. C SECTION PACK bbbb. C SECTION PACK cccc. C-SECTION PACK dddd. SECTION PACK (CSSJE)642-LF eeee. C-SECTION PACK ffff. C-SECTION PACK-RFD gggg. C-SECTION DELIVERY PACK-LF hhhh. C-SECTION PACK iiii. C SECTION PACK jjjj. C-SECTION PACK kkkk. C SECTION llll. C SECTION PLUS PACK mmmm. C SECTION PACK-6220 nnnn. C-SECTION PACK oooo. C-SECTION PACK pppp. C-SECTION PACK - WCH qqqq. C SECTION WITH BASIN PACK rrrr. PHP C-SECTION PACK-LF ssss. C-SECTION KIT tttt. C SECTION PACK uuuu. C-SECTION vvvv. C-SECTION I PACK-LF wwww. C-SECTION PACK 2 xxxx. C-SECTION PACK-LF yyyy. C-SECTION PACK zzzz. C-SECTION PACK aaaaa. C SECTION PACK bbbbb. C-SECTION PACK ccccc. C SECTION ddddd. C SECTION PACK-LF eeeee. C SECTION PACK-LF fffff. BSMI CSECTION BIRTHING PACK ggggg. C-SECTION PACK hhhhh. C SECTION PACK-LF iiiii. C-SECTION PACK jjjjj. C SECTION PACK kkkkk. C SECTION lllll. PK, L&D-C SECTION mmmmm. C-SECTION PACK nnnnn. C SECTION ooooo. C-SECTION PACK ppppp. C-SECTION SMMC qqqqq. C SECTION PACK rrrrr. C SECTION PACK sssss. C-SECTION PACK ttttt. C SECTION #2 SHARED uuuuu. C SECTION #3 SHARED vvvvv. C SECTION wwwww. C-SECTION PACK xxxxx. CESAREAN BIRTH PACK yyyyy. C SECTION PACK-LF zzzzz. C-SECTION PACK aaaaaa. C-SECTION PACK-LF bbbbbb. C SECTION PACK cccccc. C-SECTION PACK dddddd. C-SECTION eeeeee. C-SECTION ffffff. C SECTION gggggg. C-SECTION hhhhhh. C SECTION iiiiii. C-SECTION jjjjjj. C-SECTION kkkkkk. PROHEALTH C-SECTION llllll. C SECTION mmmmmm. C SECTION nnnnnn. C-SECTION oooooo. C-SECTION pppppp. C-SECTION PACK qqqqqq. C SECTION rrrrrr. C SECTION ssssss. C-SECTION tttttt. C SECTION uuuuuu. C-SECTION - SMH vvvvvv. C-SECTION MRMC wwwwww. SCHED C SECTION xxxxxx. C-SECTION yyyyyy. C-SECTION -LF zzzzzz. ADVENTIST C-SECTION PACK aaaaaaa. C-SECTION PK-LF bbbbbbb. C-SECTION PROCEDURE ccccccc. C-SECTION II-LF ddddddd. C-SECTION I-LF eeeeeee. C-SECTION PACK fffffff. C-BIRTH PACK-LF ggggggg. C-SECTION PACK hhhhhhh. THEDACARE C-SECTION iiiiiii. C-SECTION BASIN PACK jjjjjjj. C-SECTION PACK kkkkkkk. C-SECTION PACK-LF lllllll. PPH C-SECTION PACK-LF mmmmmmm. C SECTION PACK-LF nnnnnnn. C-SECTION PACK ooooooo. C-SECTION PACK-LF

Z-1092-2023
Recall number
Z-1092-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
11,886 cases (27,144 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. C-SECTION OR 30 CDS, Item Number: CDS820075W, Case UDI/GTIN: 40195327209798, Unit UDI/GTIN: 10195327209797, Lot Number: 22JBX603,22JBX483; b. C-SECTION CDS, Item Number: CDS830218J, Case UDI/GTIN: 40888277530172, Unit UDI/GTIN: 10888277530171, Lot Number: 22JBV584; c. C-SECTION CDS, Item Number: CDS980747J, Case UDI/GTIN: 40193489923613, Unit UDI/GTIN: 10193489923612, Lot Number: 22JBO006; d. C-SECTION CDS, Item Number: CDS981430C, Case UDI/GTIN: 40193489260879, Unit UDI/GTIN: 10193489260878, Lot Number: 22JMG179; e. MAJOR ORTHO CDS-LF, Item Number: CDS982233G, Case UDI/GTIN: 40193489986212, Unit UDI/GTIN: 10193489986211, Lot Number: 22JMG573; f. C-SECTION CDS, Item Number: CDS982367I, Case UDI/GTIN: 40193489312349, Unit UDI/GTIN: 10193489312348, Lot Number: 22KBE753,22KBC690; g. C-SECTION CDS, Item Number: CDS983117G, Case UDI/GTIN: 40195327192113, Unit UDI/GTIN: 10195327192112, Lot Number: 22IBR943; h. C-SECTION PROCEDURE, Item Number: CDS983450L, Case UDI/GTIN: 40193489372336, Unit UDI/GTIN: 10193489372335, Lot Number: 22KBE444,22IBD865,22IBE112; i. C-SECTION CDS-LF, Item Number: CDS983869I, Case UDI/GTIN: 40888277752734, Unit UDI/GTIN: 10888277752733, Lot Number: 22JDB259; j. C-SECTION CDS, Item Number: CDS983917M, Case UDI/GTIN: 40193489402712, Unit UDI/GTIN: 10193489402711, Lot Number: 22JBO248; k. C-SECTION CDS, Item Number: CDS984354C, Case UDI/GTIN: 40193489738187, Unit UDI/GTIN: 10193489738186, Lot Number: 22JBC335; l. C-SECTION, Item Number: CDS984902K, Case UDI/GTIN: 40195327156924, Unit UDI/GTIN: 10195327156923, Lot Number: 22IBQ711,22IBL648; m. C-SECTION CDS, Item Number: CDS985206B, Case UDI/GTIN: 40889942942078, Unit UDI/GTIN: 10889942942077, Lot Number: 22JBL398; n. C-SECTION PACK-LF, Item Number: DYNJ0173422AF, Case UDI/GTIN: 40195327097579, Unit UDI/GTIN: 10195327097578, Lot Number: 22JMA807; o. C-SECTION PACK-LF, Item Number: DYNJ0188507C, Case UDI/GTIN: 40889942053491, Unit UDI/GTIN: 10889942053490, Lot Number: 22JBY657,22IBI286; p. C-SECTION PACK-LF, Item Number: DYNJ0200274P, Case UDI/GTIN: 40889942054115, Unit UDI/GTIN: 10889942054114, Lot Number: 22IMG322; q. C-SECTION PACK-LF, Item Number: DYNJ0365888N, Case UDI/GTIN: 40195327045273, Unit UDI/GTIN: 10195327045272, Lot Number: 22IMF444,22HMF014; r. C-BIRTH PACK-LF, Item Number: DYNJ0366291M, Case UDI/GTIN: 40889942059615, Unit UDI/GTIN: 10889942059614, Lot Number: 22IME718; s. C SECTION PACK-LF, Item Number: DYNJ0367189M, Case UDI/GTIN: 40193489788298, Unit UDI/GTIN: 10193489788297, Lot Number: 22IMG638,22HMC273; t. C-SECTION PACK-LF, Item Number: DYNJ0367679W, Case UDI/GTIN: 40193489617369, Unit UDI/GTIN: 10193489617368, Lot Number: 22JMI197,22IMD016; u. C SECTION PACK-LF, Item Number: DYNJ0376534Q, Case UDI/GTIN: 40195327237173, Unit UDI/GTIN: 10195327237172, Lot Number: 22IBE468; v. C-SECTION PACK-LF, Item Number: DYNJ0382235G, Case UDI/GTIN: 40889942435020, Unit UDI/GTIN: 10889942435029, Lot Number: 22IBC549,22IBC247,22HBG107; w. C SECTION PACK-LF, Item Number: DYNJ0397841N, Case UDI/GTIN: 40193489824064, Unit UDI/GTIN: 10193489824063, Lot Number: 22IBL780; x. C-SECTION PACK-LF, Item Number: DYNJ04609I, Case UDI/GTIN: 40193489552707, Unit UDI/GTIN: 10193489552706, Lot Number: 22IMA202; y. C-SECTION PACK, Item Number: DYNJ04620S, Case UDI/GTIN: 40195327135851, Unit UDI/GTIN: 10195327135850, Lot Number: 22IMB266; z. C-SECTION PACK-LF, Item Number: DYNJ04724Q, Case UDI/GTIN: 40193489554015, Unit UDI/GTIN: 10193489554014, Lot Number: 22IMF982; aa. C-SECTION PACK-LF, Item Number: DYNJ0508830M, Case UDI/GTIN: 40193489579247, Unit UDI/GTIN: 10193489579246, Lot Number: 22IMD130; bb. C-SECTION PACK-LF, Item Number: DYNJ0551773O, Case UDI/GTIN: 40193489268622, Unit UDI/GTIN: 10193489268621, Lot Number: 22JBS505; cc. C-SECTION PACK-LF, Item Number: DYNJ06584K, Case UDI/GTIN: 40193489420525, Unit UDI/GTIN: 10193489420524, Lot Number: 22JBY658,22IBU471,22HBL261; dd. C-BIRTH SETUP PACK-LF, Item Number: DYNJ0781722T, Case UDI/GTIN: 40193489226356, Unit UDI/GTIN: 10193489226355, Lot Number: 22JMG062; ee. C-SECTION PACK-LF, Item Number: DYNJ07836Q, Case UDI/GTIN: 40195327209552, Unit UDI/GTIN: 10195327209551, Lot Number: 22IBO410; ff. C-SECTION PACK-LF, Item Number: DYNJ0842739K, Case UDI/GTIN: 40193489359634, Unit UDI/GTIN: 10193489359633, Lot Number: 22JDB302; gg. C-SECTION PACK-LF, Item Number: DYNJ0843654G, Case UDI/GTIN: 40889942402855, Unit UDI/GTIN: 10889942402854, Lot Number: 22IDB683,22IDA305; hh. C SECTION PACK-LF, Item Number: DYNJ0923021, Case UDI/GTIN: 40889942099642, Unit UDI/GTIN: 10889942099641, Lot Number: 22JMH549,22IMF460; ii. C-SECTION PACK-LF, Item Number: DYNJ15232M, Case UDI/GTIN: 40195327231744, Unit UDI/GTIN: 10195327231743, Lot Number: 22IMH405; jj. C-SECTION TRAY, Item Number: DYNJ15494G, Case UDI/GTIN: 40193489961196, Unit UDI/GTIN: 10193489961195, Lot Number: 22IBI076; kk. C-SECTION PACK, Item Number: DYNJ15726I, Case UDI/GTIN: 40193489832403, Unit UDI/GTIN: 10193489832402, Lot Number: 22JBU168; ll. C-SECTION PACK-LF, Item Number: DYNJ16672I, Case UDI/GTIN: 40193489990752, Unit UDI/GTIN: 10193489990751, Lot Number: 22JBK965,22IBL997,22HBU474,22HBV462; mm. C-SECTION PACK, Item Number: DYNJ19958P, Case UDI/GTIN: 40193489867733, Unit UDI/GTIN: 10193489867732, Lot Number: 22JMI344,22IMG005,22HME230; nn. C-SECTION PACK, Item Number: DYNJ20135M, Case UDI/GTIN: 40193489905534, Unit UDI/GTIN: 10193489905533, Lot Number: 22JBS400; oo. C-SECTION, Item Number: DYNJ22368I, Case UDI/GTIN: 40193489780513, Unit UDI/GTIN: 10193489780512, Lot Number: 22IBN332; pp. C-SECTION PACK, Item Number: DYNJ24120C, Case UDI/GTIN: 40884389396507, Unit UDI/GTIN: 10884389396506, Lot Number: 22IBF425; qq. SVMMC C-SECTION PACK, Item Number: DYNJ24632K, Case UDI/GTIN: 40195327058624, Unit UDI/GTIN: 10195327058623, Lot Number: 22JLB138,22ILA591; rr. C-SECTION PACK-LF, Item Number: DYNJ26665J, Case UDI/GTIN: 40889942112136, Unit UDI/GTIN: 10889942112135, Lot Number: 22JBW002; ss. C-SECTION SETUP PACK, Item Number: DYNJ27751F, Case UDI/GTIN: 40195327228706, Unit UDI/GTIN: 10195327228705, Lot Number: 22JDA003,22HDC395,22HDA918; tt. C-SECTION PACK, Item Number: DYNJ29034F, Case UDI/GTIN: 40193489461146, Unit UDI/GTIN: 10193489461145, Lot Number: 22IME948; uu. C-SECTION PACK, Item Number: DYNJ30483F, Case UDI/GTIN: 40193489912419, Unit UDI/GTIN: 10193489912418, Lot Number: 22JMB299,22HMB825; vv. C-SECTION PACK *STANDARD*, Item Number: DYNJ30609G, Case UDI/GTIN: 40193489301541, Unit UDI/GTIN: 10193489301540, Lot Number: 22IMG006; ww. C-SECTION PACK, Item Number: DYNJ30610D, Case UDI/GTIN: 40889942491972, Unit UDI/GTIN: 10889942491971, Lot Number: 22HDC051; xx. C-SECTION PACK, Item Number: DYNJ31011D, Case UDI/GTIN: 40889942383413, Unit UDI/GTIN: 10889942383412, Lot Number: 22JBR171; yy. C-SECTION PACK, Item Number: DYNJ32011G, Case UDI/GTIN: 40195327067046, Unit UDI/GTIN: 10195327067045, Lot Number: 22JMH079; zz. C-SECTION 83305, MERCY REG, Item Number: DYNJ32059F, Case UDI/GTIN: 40193489822497, Unit UDI/GTIN: 10193489822496, Lot Number: 22IBV950; aaa. CUH C-SECTION PACK-LF, Item Number: DYNJ32253G, Case UDI/GTIN: 40195327066537, Unit UDI/GTIN: 10195327066536, Lot Number: 22IBJ049; bbb. C-SECTION PACK-LF, Item Number: DYNJ33059B, Case UDI/GTIN: 40193489950947, Unit UDI/GTIN: 10193489950946, Lot Number: 22JBO407,22IBG828,22HBR300; ccc. C-SECTION PACK, Item Number: DYNJ33188B, Case UDI/GTIN: 40888277746283, Unit UDI/GTIN: 10888277746282, Lot Number: 22JMH212,22IMI213; ddd. C-SECTION PACK, Item Number: DYNJ33550B, Case UDI/GTIN: 40889942435686, Unit UDI/GTIN: 10889942435685, Lot Number: 22JMF403; eee. C-SECTION PACK, Item Number: DYNJ33799C, Case UDI/GTIN: 40889942447153, Unit UDI/GTIN: 10889942447152, Lot Number: 22JBI238,22HBG189; fff. C-SECTION PK, Item Number: DYNJ34266B, Case UDI/GTIN: 40888277246516, Unit UDI/GTIN: 10888277246515, Lot Number: 22IBK679; ggg. C-SECTION, Item Number: DYNJ34431G, Case UDI/GTIN: 40193489834957, Unit UDI/GTIN: 10193489834956, Lot Number: 22JBN841; hhh. C-SECTION PACK, Item Number: DYNJ36310K, Case UDI/GTIN: 40193489443456, Unit UDI/GTIN: 10193489443455, Lot Number: 22JMG326; iii. ST JO WEST C-SECTION BASIN-LF, Item Number: DYNJ37027A, Case UDI/GTIN: 40889942418320, Unit UDI/GTIN: 10889942418329, Lot Number: 22JBR330,22HBT598; jjj. C SECTION PACK, Item Number: DYNJ37622C, Case UDI/GTIN: 40884389864235, Unit UDI/GTIN: 10884389864234, Lot Number: 22IBT225; kkk. C-SECTION PACK, Item Number: DYNJ38350J, Case UDI/GTIN: 40195327129959, Unit UDI/GTIN: 10195327129958, Lot Number: 22JMC173,22IME739,22HMD564; lll. C SECTION PACK, Item Number: DYNJ38440C, Case UDI/GTIN: 40195327061792, Unit UDI/GTIN: 10195327061791, Lot Number: 22JMC367,22IMF067; mmm. C SECTION DELIVERY, Item Number: DYNJ39375F, Case UDI/GTIN: 40193489418980, Unit UDI/GTIN: 10193489418989, Lot Number: 22IBG340; nnn. C-SECTION PACK, Item Number: DYNJ40458B, Case UDI/GTIN: 40889942109334, Unit UDI/GTIN: 10889942109333, Lot Number: 22IBS430,22HBH047; ooo. C-SECTION PACK, Item Number: DYNJ40503B, Case UDI/GTIN: 40193489614931, Unit UDI/GTIN: 10193489614930, Lot Number: 22IDB276; ppp. C SECTION, Item Number: DYNJ41268B, Case UDI/GTIN: 40193489487627, Unit UDI/GTIN: 10193489487626, Lot Number: 22IMF995,22IMF998; qqq. WR C SECTION PACK-LF, Item Number: DYNJ41570K, Case UDI/GTIN: 40195327089772, Unit UDI/GTIN: 10195327089771, Lot Number: 22IMF970,22IMG359; rrr. C-SECTION PACK, Item Number: DYNJ42226D, Case UDI/GTIN: 40195327017935, Unit UDI/GTIN: 10195327017934, Lot Number: 22IMG051,22IMG068; sss. PK, L&D-C SECTION, Item Number: DYNJ42476I, Case UDI/GTIN: 40193489266017, Unit UDI/GTIN: 10193489266016, Lot Number: 22JBU242; ttt. C-SECTION PACK HIGHLAND-LF, Item Number: DYNJ42634B, Case UDI/GTIN: 40888277582805, Unit UDI/GTIN: 10888277582804, Lot Number: 22IBD370; uuu. C- SECTION, Item Number: DYNJ42651, Case UDI/GTIN: 40888277003584, Unit UDI/GTIN: 10888277003583, Lot Number: 22IME346,22IME347,22HMC131; vvv. C SECTION PACK-LF, Item Number: DYNJ42850A, Case UDI/GTIN: 40193489880909, Unit UDI/GTIN: 10193489880908, Lot Number: 22JBN852; www. C-SECTION PACK, Item Number: DYNJ42946A, Case UDI/GTIN: 40195327196838, Unit UDI/GTIN: 10195327196837, Lot Number: 22IBV689,22HBH787; xxx. C-SECTION PACK, Item Number: DYNJ43284D, Case UDI/GTIN: 40888277984128, Unit UDI/GTIN: 10888277984127, Lot Number: 22IMG361; yyy. C SECTION PACK, Item Number: DYNJ43732F, Case UDI/GTIN: 40193489549370, Unit UDI/GTIN: 10193489549379, Lot Number: 22IBI952; zzz. PK, L&D-C SECTION, Item Number: DYNJ43746C, Case UDI/GTIN: 40193489310635, Unit UDI/GTIN: 10193489310634, Lot Number: 22JBO122; aaaa. C SECTION PACK, Item Number: DYNJ43810A, Case UDI/GTIN: 40193489298056, Unit UDI/GTIN: 10193489298055, Lot Number: 22IBK239; bbbb. C SECTION PACK, Item Number: DYNJ46508F, Case UDI/GTIN: 40195327111787, Unit UDI/GTIN: 10195327111786, Lot Number: 22JME929; cccc. C-SECTION PACK, Item Number: DYNJ47220C, Case UDI/GTIN: 40889942131359, Unit UDI/GTIN: 10889942131358, Lot Number: 22JMD043; dddd. SECTION PACK (CSSJE)642-LF, Item Number: DYNJ47485C, Case UDI/GTIN: 40193489586597, Unit UDI/GTIN: 10193489586596, Lot Number: 22IMI230; eeee. C-SECTION PACK, Item Number: DYNJ47606B, Case UDI/GTIN: 40193489730693, Unit UDI/GTIN: 10193489730692, Lot Number: 22IBV197; ffff. C-SECTION PACK-RFD, Item Number: DYNJ47761K, Case UDI/GTIN: 40193489896986, Unit UDI/GTIN: 10193489896985, Lot Number: 22IME390; gggg. C-SECTION DELIVERY PACK-LF, Item Number: DYNJ47808F, Case UDI/GTIN: 40195327232604, Unit UDI/GTIN: 10195327232603, Lot Number: 22IMB729; hhhh. C-SECTION PACK, Item Number: DYNJ48272, Case UDI/GTIN: 40888277575371, Unit UDI/GTIN: 10888277575370, Lot Number: 22IBO504,22HMD672; iiii. C SECTION PACK, Item Number: DYNJ48483D, Case UDI/GTIN: 40195327030811, Unit UDI/GTIN: 10195327030810, Lot Number: 22JMI251; jjjj. C-SECTION PACK, Item Number: DYNJ48746A, Case UDI/GTIN: 40889942385691, Unit UDI/GTIN: 10889942385690, Lot Number: 22JMA582; kkkk. C SECTION, Item Number: DYNJ49172G, Case UDI/GTIN: 40193489308243, Unit UDI/GTIN: 10193489308242, Lot Number: 22IMC797,22HME909; llll. C SECTION PLUS PACK, Item Number: DYNJ49370D, Case UDI/GTIN: 40193489213318, Unit UDI/GTIN: 10193489213317, Lot Number: 22JBO103,22HBR997,22HBG119; mmmm. C SECTION PACK-6220, Item Number: DYNJ49519A, Case UDI/GTIN: 40889942024835, Unit UDI/GTIN: 10889942024834, Lot Number: 22IBN420; nnnn. C-SECTION PACK, Item Number: DYNJ49668A, Case UDI/GTIN: 40889942390176, Unit UDI/GTIN: 10889942390175, Lot Number: 22JBS277,22IBR285; oooo. C-SECTION PACK, Item Number: DYNJ49771, Case UDI/GTIN: 40888277881144, Unit UDI/GTIN: 10888277881143, Lot Number: 22IBQ282; pppp. C-SECTION PACK - WCH, Item Number: DYNJ49829F, Case UDI/GTIN: 40193489631570, Unit UDI/GTIN: 10193489631579, Lot Number: 22JBX669; qqqq. C SECTION WITH BASIN PACK, Item Number: DYNJ51378G, Case UDI/GTIN: 40193489996389, Unit UDI/GTIN: 10193489996388, Lot Number: 22IBN196; rrrr. PHP C-SECTION PACK-LF, Item Number: DYNJ51603D, Case UDI/GTIN: 40195327167050, Unit UDI/GTIN: 10195327167059, Lot Number: 22JMG359,22IMA243; ssss. C-SECTION KIT, Item Number: DYNJ51655C, Case UDI/GTIN: 40195327187850, Unit UDI/GTIN: 10195327187859, Lot Number: 22IME130; tttt. C SECTION PACK, Item Number: DYNJ51872D, Case UDI/GTIN: 40195327043439, Unit UDI/GTIN: 10195327043438, Lot Number: 22JBI664; uuuu. C-SECTION, Item Number: DYNJ51997, Case UDI/GTIN: 40889942233107, Unit UDI/GTIN: 10889942233106, Lot Number: 22JBP756,22IBR427; vvvv. C-SECTION I PACK-LF, Item Number: DYNJ52040F, Case UDI/GTIN: 40195327096145, Unit UDI/GTIN: 10195327096144, Lot Number: 22JBO202,22JBN048,22HBG758; wwww. C-SECTION PACK 2, Item Number: DYNJ52168A, Case UDI/GTIN: 40193489539739, Unit UDI/GTIN: 10193489539738, Lot Number: 22JBD226,22IBP554,22IBM605; xxxx. C-SECTION PACK-LF, Item Number: DYNJ52908A, Case UDI/GTIN: 40889942851981, Unit UDI/GTIN: 10889942851980, Lot Number: 22IMC339,22HMC091; yyyy. C-SECTION PACK, Item Number: DYNJ52931D, Case UDI/GTIN: 40195327200221, Unit UDI/GTIN: 10195327200220, Lot Number: 22IBR773; zzzz. C-SECTION PACK, Item Number: DYNJ53386C, Case UDI/GTIN: 40195327169696, Unit UDI/GTIN: 10195327169695, Lot Number: 22JMF746; aaaaa. C SECTION PACK, Item Number: DYNJ53399I, Case UDI/GTIN: 40193489968478, Unit UDI/GTIN: 10193489968477, Lot Number: 22JMF705; bbbbb. C-SECTION PACK, Item Number: DYNJ53598F, Case UDI/GTIN: 40195327055821, Unit UDI/GTIN: 10195327055820, Lot Number: 22IMB353,22IMB057; ccccc. C SECTION, Item Number: DYNJ53654F, Case UDI/GTIN: 40193489454674, Unit UDI/GTIN: 10193489454673, Lot Number: 22IBI089; ddddd. C SECTION PACK-LF, Item Number: DYNJ54186A, Case UDI/GTIN: 40195327062607, Unit UDI/GTIN: 10195327062606, Lot Number: 22JMF820; eeeee. C SECTION PACK-LF, Item Number: DYNJ54374J, Case UDI/GTIN: 40193489404075, Unit UDI/GTIN: 10193489404074, Lot Number: 22IBM226; fffff. BSMI CSECTION BIRTHING PACK, Item Number: DYNJ54946G, Case UDI/GTIN: 40195327135455, Unit UDI/GTIN: 10195327135454, Lot Number: 22IBJ472,22HBA609; ggggg. C-SECTION PACK, Item Number: DYNJ55336A, Case UDI/GTIN: 40889942781097, Unit UDI/GTIN: 10889942781096, Lot Number: 22KBB430; hhhhh. C SECTION PACK-LF, Item Number: DYNJ55466C, Case UDI/GTIN: 40193489408158, Unit UDI/GTIN: 10193489408157, Lot Number: 22IBN820,22HBW539; iiiii. C-SECTION PACK, Item Number: DYNJ55719, Case UDI/GTIN: 40889942574590, Unit UDI/GTIN: 10889942574599, Lot Number: 22IBR318; jjjjj. C SECTION PACK, Item Number: DYNJ57193A, Case UDI/GTIN: 40193489647656, Unit UDI/GTIN: 10193489647655, Lot Number: 22IBF463; kkkkk. C SECTION, Item Number: DYNJ57622, Case UDI/GTIN: 40889942757245, Unit UDI/GTIN: 10889942757244, Lot Number: 22IBF901; lllll. PK, L&D-C SECTION, Item Number: DYNJ58239B, Case UDI/GTIN: 40195327248766, Unit UDI/GTIN: 10195327248765, Lot Number: 22IMH256,22IMH497; mmmmm. C-SECTION PACK, Item Number: DYNJ58493A, Case UDI/GTIN: 40193489517423, Unit UDI/GTIN: 10193489517422, Lot Number: 22JBU325; nnnnn. C SECTION, Item Number: DYNJ58551, Case UDI/GTIN: 40889942870982, Unit UDI/GTIN: 10889942870981, Lot Number: 22JBO158; ooooo. C-SECTION PACK, Item Number: DYNJ59414A, Case UDI/GTIN: 40195327066452, Unit UDI/GTIN: 10195327066451, Lot Number: 22JMF097; ppppp. C-SECTION SMMC, Item Number: DYNJ59457A, Case UDI/GTIN: 40195327243266, Unit UDI/GTIN: 10195327243265, Lot Number: 22JMD987; qqqqq. C SECTION PACK, Item Number: DYNJ61573, Case UDI/GTIN: 40193489601078, Unit UDI/GTIN: 10193489601077, Lot Number: 22JMA868,22IMF177; rrrrr. C SECTION PACK, Item Number: DYNJ64493A, Case UDI/GTIN: 40193489323260, Unit UDI/GTIN: 10193489323269, Lot Number: 22IBI098; sssss. C-SECTION PACK, Item Number: DYNJ64678A, Case UDI/GTIN: 40195327225996, Unit UDI/GTIN: 10195327225995, Lot Number: 22JDB087; ttttt. C SECTION #2 SHARED, Item Number: DYNJ64773C, Case UDI/GTIN: 40195327221066, Unit UDI/GTIN: 10195327221065, Lot Number: 22IDA431; uuuuu. C SECTION #3 SHARED, Item Number: DYNJ64774D, Case UDI/GTIN: 40195327233885, Unit UDI/GTIN: 10195327233884, Lot Number: 22IDC063,22IDA788; vvvvv. C SECTION, Item Number: DYNJ65646B, Case UDI/GTIN: 40195327146789, Unit UDI/GTIN: 10195327146788, Lot Number: 22IBF374; wwwww. C-SECTION PACK, Item Number: DYNJ65961B, Case UDI/GTIN: 40193489984300, Unit UDI/GTIN: 10193489984309, Lot Number: 22IME243; xxxxx. CESAREAN BIRTH PACK, Item Number: DYNJ67620, Case UDI/GTIN: 40193489418164, Unit UDI/GTIN: 10193489418163, Lot Number: 22JBX125,22HBR751,22HBS988; yyyyy. C SECTION PACK-LF, Item Number: DYNJ67957, Case UDI/GTIN: 40193489458979, Unit UDI/GTIN: 10193489458978, Lot Number: 22JMH427,22JMD099,22IMH525; zzzzz. C-SECTION PACK, Item Number: DYNJ68954, Case UDI/GTIN: 40193489863469, Unit UDI/GTIN: 10193489863468, Lot Number: 22JMF850; aaaaaa. C-SECTION PACK-LF, Item Number: DYNJ69445, Case UDI/GTIN: 40193489942515, Unit UDI/GTIN: 10193489942514, Lot Number: 22JBR185,22IBG076; bbbbbb. C SECTION PACK, Item Number: DYNJ82554, Case UDI/GTIN: 40195327198245, Unit UDI/GTIN: 10195327198244, Lot Number: 22JBQ815; cccccc. C-SECTION PACK, Item Number: DYNJ83021, Case UDI/GTIN: 40195327228911, Unit UDI/GTIN: 10195327228910, Lot Number: 22JBN586; dddddd. C-SECTION, Item Number: DYNJ900260A, Case UDI/GTIN: 40195327178537, Unit UDI/GTIN: 10195327178536, Lot Number: 22IBQ946; eeeeee. C-SECTION, Item Number: DYNJ900266C, Case UDI/GTIN: 40193489278430, Unit UDI/GTIN: 10193489278439, Lot Number: 22IBS357; ffffff. C SECTION, Item Number: DYNJ900794, Case UDI/GTIN: 40888277906601, Unit UDI/GTIN: 10888277906600, Lot Number: 22KBF556,22JBM372,22IBI225; gggggg. C-SECTION, Item Number: DYNJ902761D, Case UDI/GTIN: 40193489891059, Unit UDI/GTIN: 10193489891058, Lot Number: 22JMG886,22JMD346; hhhhhh. C SECTION, Item Number: DYNJ903771B, Case UDI/GTIN: 40193489935968, Unit UDI/GTIN: 10193489935967, Lot Number: 22JBN602,22JBN603,22HBX117; iiiiii. C-SECTION, Item Number: DYNJ904357D, Case UDI/GTIN: 40195327223091, Unit UDI/GTIN: 10195327223090, Lot Number: 22JBE816,22IBR279; jjjjjj. C-SECTION, Item Number: DYNJ904612F, Case UDI/GTIN: 40193489844048, Unit UDI/GTIN: 10193489844047, Lot Number: 22JBA083; kkkkkk. PROHEALTH C-SECTION, Item Number: DYNJ904879D, Case UDI/GTIN: 40193489400107, Unit UDI/GTIN: 10193489400106, Lot Number: 22KBC325; llllll. C SECTION, Item Number: DYNJ905314G, Case UDI/GTIN: 40193489930536, Unit UDI/GTIN: 10193489930535, Lot Number: 22JBR953; mmmmmm. C SECTION, Item Number: DYNJ905776C, Case UDI/GTIN: 40195327179862, Unit UDI/GTIN: 10195327179861, Lot Number: 22KBF490; nnnnnn. C-SECTION, Item Number: DYNJ905792C, Case UDI/GTIN: 40195327108428, Unit UDI/GTIN: 10195327108427, Lot Number: 22IMF389; oooooo. C-SECTION, Item Number: DYNJ906470D, Case UDI/GTIN: 40195327204243, Unit UDI/GTIN: 10195327204242, Lot Number: 22IDC048; pppppp. C-SECTION PACK, Item Number: DYNJ906557A, Case UDI/GTIN: 40193489436373, Unit UDI/GTIN: 10193489436372, Lot Number: 22IBT728; qqqqqq. C SECTION, Item Number: DYNJ906917A, Case UDI/GTIN: 40193489460378, Unit UDI/GTIN: 10193489460377, Lot Number: 22JBJ828; rrrrrr. C SECTION, Item Number: DYNJ907073, Case UDI/GTIN: 40193489337069, Unit UDI/GTIN: 10193489337068, Lot Number: 22IBE728; ssssss. C-SECTION, Item Number: DYNJ907228F, Case UDI/GTIN: 40195327247448, Unit UDI/GTIN: 10195327247447, Lot Number: 22JBC329; tttttt. C SECTION, Item Number: DYNJ907660A, Case UDI/GTIN: 40195327168668, Unit UDI/GTIN: 10195327168667, Lot Number: 22IMG417; uuuuuu. C-SECTION - SMH, Item Number: DYNJ907724A, Case UDI/GTIN: 40193489976381, Unit UDI/GTIN: 10193489976380, Lot Number: 22JBH655,22IBA564; vvvvvv. C-SECTION MRMC, Item Number: DYNJ907745B, Case UDI/GTIN: 40195327195411, Unit UDI/GTIN: 10195327195410, Lot Number: 22KBE700,22IBE731,22HBU387; wwwwww. SCHED C SECTION, Item Number: DYNJ907956, Case UDI/GTIN: 40193489949439, Unit UDI/GTIN: 10193489949438, Lot Number: 22IBQ951; xxxxxx. C-SECTION, Item Number: DYNJ908197, Case UDI/GTIN: 40195327006502, Unit UDI/GTIN: 10195327006501, Lot Number: 22JDB121; yyyyyy. C-SECTION -LF, Item Number: DYNJ9932207R, Case UDI/GTIN: 40193489624152, Unit UDI/GTIN: 10193489624151, Lot Number: 22JMD352; zzzzzz. ADVENTIST C-SECTION PACK, Item Number: DYNJADV101A, Case UDI/GTIN: 40888277576170, Unit UDI/GTIN: 10888277576179, Lot Number: 22IBS980,22HBW715; aaaaaaa. C-SECTION PK-LF, Item Number: DYNJC2363J, Case UDI/GTIN: 40195327131341, Unit UDI/GTIN: 10195327131340, Lot Number: 22HBI849,22HBI850; bbbbbbb. C-SECTION PROCEDURE, Item Number: DYNJQ9038I, Case UDI/GTIN: 40889942629948, Unit UDI/GTIN: 10889942629947, Lot Number: 22HBR429; ccccccc. C-SECTION II-LF, Item Number: DYNJS0612, Case UDI/GTIN: 40080196942504, Unit UDI/GTIN: 10080196942503, Lot Number: 22JBK525,22IBP836,22HBX278,22HBN836,22HBG183,22HBG185; ddddddd. C-SECTION I-LF, Item Number: DYNJS3038, Case UDI/GTIN: 40884389450216, Unit UDI/GTIN: 10884389450215, Lot Number: 22JDA185,22HDC283,22HDB455,22HDA724; eeeeeee. C-SECTION PACK, Item Number: DYNJT0473I, Case UDI/GTIN: 40889942954057, Unit UDI/GTIN: 10889942954056, Lot Number: 22IMH365; fffffff. C-BIRTH PACK-LF, Item Number: DYNJT1915K, Case UDI/GTIN: 40193489899376, Unit UDI/GTIN: 10193489899375, Lot Number: 22IBN792,22IBE982; ggggggg. C-SECTION PACK, Item Number: OBJ602U, Case UDI/GTIN: 40193489964470, Unit UDI/GTIN: 10193489964479, Lot Number: 22JBP919,22IBK343; hhhhhhh. THEDACARE C-SECTION, Item Number: OBP112X, Case UDI/GTIN: 40195327147649, Unit UDI/GTIN: 10195327147648, Lot Number: 22HBB733; iiiiiii. C-SECTION BASIN PACK, Item Number: OBP211C, Case UDI/GTIN: 40884389069746, Unit UDI/GTIN: 10884389069745, Lot Number: 22IBM827,22HBW292; jjjjjjj. C-SECTION PACK, Item Number: OBP323G, Case UDI/GTIN: 40193489886413, Unit UDI/GTIN: 10193489886412, Lot Number: 22IBA633,22HBI799,22HBI800; kkkkkkk. C-SECTION PACK-LF, Item Number: PHS164410001, Case UDI/GTIN: 40889942035749, Unit UDI/GTIN: 10889942035748, Lot Number: 22IMG290; lllllll. PPH C-SECTION PACK-LF, Item Number: PHS322253008B, Case UDI/GTIN: 40193489636889, Unit UDI/GTIN: 10193489636888, Lot Number: 22IBN335; mmmmmmm. C SECTION PACK-LF, Item Number: PHS410129014C, Case UDI/GTIN: 40889942936961, Unit UDI/GTIN: 10889942936960, Lot Number: 22JBC784; nnnnnnn. C-SECTION PACK, Item Number: PHS774420G, Case UDI/GTIN: 40889942942511, Unit UDI/GTIN: 10889942942510, Lot Number: 22IMC958; ooooooo. C-SECTION PACK-LF, Item Number: PHS988341C, Case UDI/GTIN: 40889942484820, Unit UDI/GTIN: 10889942484829, Lot Number: 22IMH544

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 34 of 38

Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF

Z-1093-2023
Recall number
Z-1093-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
1,258 cases (2,154 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IMD263; b. LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/GTIN: 10195327008697, Lot Number: 22JME637; c. TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/GTIN: 10193489651263, Lot Number: 22JBM626,22JBK303; d. CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/GTIN: 10195327164607, Lot Number: 22JBM359; e. LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/GTIN: 10193489413113, Lot Number: 22HBU206,22HBU964; f. GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/GTIN: 10195327143985, Lot Number: 22IBA054; g. MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/GTIN: 10193489899924, Lot Number: 22JBN433,22IBE548; h. MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 40195327171507, Unit UDI/GTIN: 10195327171506, Lot Number: 22IDC076,22IDA825,22IDA274; i. VAG. HYST TRAY-LF, Item Number: DYNJ0209066N, Case UDI/GTIN: 40889942054429, Unit UDI/GTIN: 10889942054428, Lot Number: 22JME324; j. VAGINAL HYSTERECTOMY PACK-LF, Item Number: DYNJ0373807K, Case UDI/GTIN: 40195327225682, Unit UDI/GTIN: 10195327225681, Lot Number: 22JBO175; k. HYSTERECTOMY PACK-LF, Item Number: DYNJ20485L, Case UDI/GTIN: 40195327024360, Unit UDI/GTIN: 10195327024369, Lot Number: 22IDA372; l. HYSTERECTOMY PACK, Item Number: DYNJ25971I, Case UDI/GTIN: 40888277763525, Unit UDI/GTIN: 10888277763524, Lot Number: 22JBO188; m. MAJOR ABD PROCEDURE PACK-LF, Item Number: DYNJ36731F, Case UDI/GTIN: 40195327148196, Unit UDI/GTIN: 10195327148195, Lot Number: 22IBA619; n. GYN PACK, Item Number: DYNJ40409C, Case UDI/GTIN: 40889942215929, Unit UDI/GTIN: 10889942215928, Lot Number: 22JBM950; o. BLADDER SLING PACK, Item Number: DYNJ43887, Case UDI/GTIN: 40888277073266, Unit UDI/GTIN: 10888277073265, Lot Number: 22JBN288,22IBD109; p. PERI/GYN PACK-RFD, Item Number: DYNJ48918J, Case UDI/GTIN: 40193489729994, Unit UDI/GTIN: 10193489729993, Lot Number: 22JMD314; q. ROBOT HYSTERECTOMY, Item Number: DYNJ49221C, Case UDI/GTIN: 40193489313766, Unit UDI/GTIN: 10193489313765, Lot Number: 22KMA208; r. VAG HYST, Item Number: DYNJ51386B, Case UDI/GTIN: 40193489944229, Unit UDI/GTIN: 10193489944228, Lot Number: 22IBJ500; s. GYN MAJOR PACK, Item Number: DYNJ52095I, Case UDI/GTIN: 40193489996945, Unit UDI/GTIN: 10193489996944, Lot Number: 22IDA203; t. VAGINAL HYSTER PROCEDURE, Item Number: DYNJ53804, Case UDI/GTIN: 40889942444602, Unit UDI/GTIN: 10889942444601, Lot Number: 22JDB955; u. TLH PACK, Item Number: DYNJ63145A, Case UDI/GTIN: 40193489979573, Unit UDI/GTIN: 10193489979572, Lot Number: 22JBN742,22IBK842; v. TLH PACK, Item Number: DYNJ80430, Case UDI/GTIN: 40195327038473, Unit UDI/GTIN: 10195327038472, Lot Number: 22HBN532; w. VAG HYST PACK, Item Number: DYNJ82634, Case UDI/GTIN: 40195327199563, Unit UDI/GTIN: 10195327199562, Lot Number: 22JBY522; x. LITHOTOMY-LF, Item Number: DYNJ900721C, Case UDI/GTIN: 40193489951609, Unit UDI/GTIN: 10193489951608, Lot Number: 22KBC673; y. MAJOR LITHOTOMY, Item Number: DYNJ902373I, Case UDI/GTIN: 40195327224760, Unit UDI/GTIN: 10195327224769, Lot Number: 22JBO747; z. LAVH, Item Number: DYNJ903392F, Case UDI/GTIN: 40193489467506, Unit UDI/GTIN: 10193489467505, Lot Number: 22JBR451; aa. LAVH, Item Number: DYNJ904335B, Case UDI/GTIN: 40193489926720, Unit UDI/GTIN: 10193489926729, Lot Number: 22JBU057; bb. D&C / GYN, Item Number: DYNJ906514B, Case UDI/GTIN: 40193489998567, Unit UDI/GTIN: 10193489998566, Lot Number: 22IBP589,22IBD796; cc. LAPAROSCOPIC HYSTERECTOMY, Item Number: DYNJ906844A, Case UDI/GTIN: 40195327025954, Unit UDI/GTIN: 10195327025953, Lot Number: 22JMG630; dd. FS LAP TUBAL LIGATION, Item Number: DYNJ908306, Case UDI/GTIN: 40195327030316, Unit UDI/GTIN: 10195327030315, Lot Number: 22KBE781,22JBO684; ee. LAVH, Item Number: DYNJQ9041Q, Case UDI/GTIN: 40193489850605, Unit UDI/GTIN: 10193489850604, Lot Number: 22JBG106,22IBB420,22IBC141; ff. ABD HYST PACK-LF, Item Number: DYNJT1912G, Case UDI/GTIN: 40888277809056, Unit UDI/GTIN: 10888277809055, Lot Number: 22HBW646; gg. VAG HYST PK-LF, Item Number: DYNJT1913J, Case UDI/GTIN: 40193489976473, Unit UDI/GTIN: 10193489976472, Lot Number: 22IBQ666,22HBU577

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 35 of 38

Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI

Z-1094-2023
Recall number
Z-1094-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
1,212 cases (2,101 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. CELEBRATION ROBOTIC CDS, Item Number: CDS983612C, Case UDI/GTIN: 40884389768687, Unit UDI/GTIN: 10884389768686, Lot Number: 22KBE707,22JBX839,22JBX843; b. DAVINCI CDS UCC-LF, Item Number: CDS984663G, Case UDI/GTIN: 40193489323772, Unit UDI/GTIN: 10193489323771, Lot Number: 22JBX614; c. ROBOTICS PACK-LF, Item Number: DYNJ0038258B, Case UDI/GTIN: 40889942902089, Unit UDI/GTIN: 10889942902088, Lot Number: 22IBO524,22HBV626,22HBV627; d. ROBOTICS PACK-LF, Item Number: DYNJ0046667A, Case UDI/GTIN: 40889942160397, Unit UDI/GTIN: 10889942160396, Lot Number: 22JMA806,22IMC899; e. ROBOTIC PACK, Item Number: DYNJ04135B, Case UDI/GTIN: 40888277893536, Unit UDI/GTIN: 10888277893535, Lot Number: 22JBX625,22IBE470; f. PELVISCOPY PACK-LF, Item Number: DYNJ0843760G, Case UDI/GTIN: 40193489899161, Unit UDI/GTIN: 10193489899160, Lot Number: 22IDC034; g. CUSTOM LITHOTOMY ROBOT PACK, Item Number: DYNJ35094C, Case UDI/GTIN: 40889942764991, Unit UDI/GTIN: 10889942764990, Lot Number: 22IBR203; h. PERI GYN PACK, Item Number: DYNJ39021B, Case UDI/GTIN: 40195327191048, Unit UDI/GTIN: 10195327191047, Lot Number: 22JBI763,22IBJ622; i. ROBOTICS PACK, Item Number: DYNJ42016B, Case UDI/GTIN: 40888277938312, Unit UDI/GTIN: 10888277938311, Lot Number: 22JBQ809,22IBG293; j. LAP HYSTO PACK, Item Number: DYNJ43888, Case UDI/GTIN: 40888277073273, Unit UDI/GTIN: 10888277073272, Lot Number: 22JBC458; k. PK, ROBOTICS-ACCESSORY, Item Number: DYNJ52985F, Case UDI/GTIN: 40193489215824, Unit UDI/GTIN: 10193489215823, Lot Number: 22IBK173,22IBK797,22HBG975; l. OBS PACK, Item Number: DYNJ65258B, Case UDI/GTIN: 40193489829496, Unit UDI/GTIN: 10193489829495, Lot Number: 22IBD122; m. LAPAROSCOPY/D&C PACK, Item Number: DYNJ67569A, Case UDI/GTIN: 40195327191529, Unit UDI/GTIN: 10195327191528, Lot Number: 22JBQ481; n. PERI GYN RECTAL PACK, Item Number: DYNJ82556, Case UDI/GTIN: 40195327198269, Unit UDI/GTIN: 10195327198268, Lot Number: 22IBO110; o. TVT, Item Number: DYNJ900506B, Case UDI/GTIN: 40889942576518, Unit UDI/GTIN: 10889942576517, Lot Number: 22IBV025; p. DAVINCI DT-LF, Item Number: DYNJ900569G, Case UDI/GTIN: 40193489861434, Unit UDI/GTIN: 10193489861433, Lot Number: 22JBB568; q. ROBOTICS SI, Item Number: DYNJ902659D, Case UDI/GTIN: 40889942692416, Unit UDI/GTIN: 10889942692415, Lot Number: 22IBG173,22IBG174

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 36 of 38

Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE PACK o. OCULAR PLASTIC PACK p. OCULOPLASTIC PACK

Z-1095-2023
Recall number
Z-1095-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
260 cases (1,200 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. BASIC EYE PACK-LF, Item Number: DYNJ0842521C, Case UDI/GTIN: 40193489352383, Unit UDI/GTIN: 10193489352382, Lot Number: 22JDA005,22HDC265; b. VITRECTOMY PACK-LF, Item Number: DYNJ0843936F, Case UDI/GTIN: 40193489352390, Unit UDI/GTIN: 10193489352399, Lot Number: 22JDA822,22IDB984; c. EYE PACK-EAST-LF, Item Number: DYNJ14064, Case UDI/GTIN: 40080196931102, Unit UDI/GTIN: 10080196931101, Lot Number: 22JBC143,22IBF606; d. OSC OCULAR PLASTIC PACK-LF, Item Number: DYNJ31639B, Case UDI/GTIN: 40889942292067, Unit UDI/GTIN: 10889942292066, Lot Number: 22JBG389,22HBY420; e. EYE PACK, Item Number: DYNJ35056A, Case UDI/GTIN: 40889942227564, Unit UDI/GTIN: 10889942227563, Lot Number: 22JBL816; f. OCULOPLASTIC PACK, Item Number: DYNJ46539J, Case UDI/GTIN: 40193489997355, Unit UDI/GTIN: 10193489997354, Lot Number: 22JME546,22JME931; g. EYE PLASTIC PACK, Item Number: DYNJ47859C, Case UDI/GTIN: 40193489916066, Unit UDI/GTIN: 10193489916065, Lot Number: 22JBS972; h. PLASTIC EYE PACK, Item Number: DYNJ49413A, Case UDI/GTIN: 40888277971593, Unit UDI/GTIN: 10888277971592, Lot Number: 22KBA929; i. DR H BLEPH PACK, Item Number: DYNJ54487A, Case UDI/GTIN: 40193489587877, Unit UDI/GTIN: 10193489587876, Lot Number: 22HBG403; j. BLEPH PACK, Item Number: DYNJ62174A, Case UDI/GTIN: 40195327037780, Unit UDI/GTIN: 10195327037789, Lot Number: 22IBT956; k. OPHTHALMOLOGY PACK, Item Number: DYNJ63785, Case UDI/GTIN: 40193489760744, Unit UDI/GTIN: 10193489760743, Lot Number: 22IBN397; l. OCULOPLASTIC PACK, Item Number: DYNJ66365, Case UDI/GTIN: 40193489346627, Unit UDI/GTIN: 10193489346626, Lot Number: 22JBE699; m. BLEPH PACK, Item Number: DYNJ67875, Case UDI/GTIN: 40193489448826, Unit UDI/GTIN: 10193489448825, Lot Number: 22JBY558,22JBY531; n. EYE PACK, Item Number: DYNJ69446, Case UDI/GTIN: 40193489942546, Unit UDI/GTIN: 10193489942545, Lot Number: 22IBS350,22HBN241; o. OCULAR PLASTIC PACK, Item Number: DYNJ82588, Case UDI/GTIN: 40195327198795, Unit UDI/GTIN: 10195327198794, Lot Number: 22HBJ348; p. OCULOPLASTIC PACK, Item Number: DYNJ908778, Case UDI/GTIN: 40195327177660, Unit UDI/GTIN: 10195327177669, Lot Number: 22JBW843

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 37 of 38

Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF o. TOTAL KNEE CDS-3 p. TOTAL HIP CDS-3 q. LOWER EXTREMITY CDS-LF r. TOTAL HIP-LF s. TOTAL HIP/KNEE CDS t. SPINE PROCEDURE u. OPEN HEART v. LAMI w. UPPER EXTREMITY CDS x. LOWER EXTREMITY CDS y. KNEE ARTHROSCOPY CDS z. KNEE ARTHROSCOPY CDS-LF aa. SHOULDER CDS-LF bb. PODIATRY CDS cc. KNEE ARTHROSCOPY CDS dd. SHOULDER ARTHROSCOPY CDS ee. ACL CDS ff. CRANIOTOMY CDS gg. TOTAL KNEE CDS hh. TOTAL KNEE ii. TOTAL HIP CDS jj. NEW LONDON TOTAL KNEE CDS kk. TRAUMA CDS-LF ll. TOTAL JOINT CDS mm. CRANIOTOMY CDS-1 nn. SHOULDER CDS-1 oo. SPINE CDS-1 pp. TOTAL KNEE CDS-1 qq. TOTAL HIP CDS-1 rr. LOWER EXTREMITY CDS-2 ss. HAND CDS-2 tt. KNEE ARTHROSCOPY CDS-2 uu. HAND CDS vv. BACK CDS ww. FRACTURE TABLE CDS xx. ORTHO OP CDS yy. ARTHROSCOPY CDS zz. ORTHO MINOR CDS aaa. TOTAL JOINT KNEE CDS bbb. TOTAL JOINT HIP CDS ccc. SHOULDER CDS-LF ddd. ZALE CRANIOTOMY CDS eee. ZALE TOTAL KNEE CDS fff. ZALE EXTREMITY CDS ggg. OPEN SHOULDER CDS hhh. LOWER EXTREMITY CDS iii. FHT TOTAL HIP jjj. FHT TOTAL KNEE RPLCMNT kkk. TOTAL HIP CDS lll. TOTAL KNEE CDS mmm. CCOC ACL-LF nnn. CCOC SPINAL FUSION ooo. CCOC MAJOR EXTREMITY ppp. EXTREMITY CDS qqq. PODIATRY CDS rrr. SHOULDER CDS sss. DISTAL LEG CDS ttt. HIP NAILING CDS uuu. SHOULDER CDS vvv. TOTAL HIP CDS www. UPPER EXTREMITY CDS xxx. BASIC ORTHO CDS yyy. TOTAL HIP PROCEDURE zzz. TOTAL JOINT CDS-LF aaaa. SHOULDER CDS-LF bbbb. HAND CDS-LF cccc. KNEE ARTHROSCOPY CDS-LF dddd. TOTAL JOINT eeee. UPPER EXTREMITY CDS ffff. LOWER EXTREMITY CDS gggg. GENERAL ORTHO CDS hhhh. ARTHROSCOPY CDS iiii. KNEE ARTHROSCOPY CDS jjjj. SHOULDER ARTHROSCOPY CDS kkkk. KNEE ARTHROSCOPY CDS llll. TOTAL ORTHO CDS mmmm. GROTH LOWER EXTREMITY CDS nnnn. HIP TOTAL PACK-ANTERIOR oooo. PRAIRIE STAR SPINE CDS pppp. 4TH FLOOR SHOULDER ARTHROSCOPY qqqq. FOOT & ANKLE CDS-LF rrrr. LAMI MICRODISC-LF ssss. HIP PINNING CDS-LF tttt. KNEE ARTHROSCOPY CDS-LF uuuu. UPPER EXTREMITY CDS-LF vvvv. SPINE CDS-LF wwww. SPINE CDS-LF xxxx. LOWER EXTREMITY/ELBOW CDS yyyy. HAND CDS zzzz. KNEE ARTHROSCOPY CDS aaaaa. SPINE CDS bbbbb. TOTAL HIP CDS ccccc. KNEE ARTHROSCOPY CDS ddddd. HAND CDS eeeee. TOTAL KNEE CDS-LF fffff. SPINE MODULE CDS ggggg. UPPER EXTREMITY CDS-LF hhhhh. TOTAL JOINT CDS iiiii. TOTAL JOINT CDS jjjjj. ORTHO TRAUMA CDS kkkkk. ACF CDS lllll. CRANIOTOMY CDS mmmmm. TOTAL JOINT CDS nnnnn. ARTHROSCOPY CDS ooooo. EXTREMITY CDS ppppp. PODIATRY CDS qqqqq. LAMINECTOMY CDS rrrrr. EXTREMITY CDS sssss. TOTAL KNEE CDS ttttt. TOTAL HIP CDS uuuuu. TOTAL KNEE vvvvv. ANTERIOR HIP wwwww. HAND WRIST FOREARM xxxxx. LOWER EXTREMITY yyyyy. TOTAL HIP zzzzz. TOTAL KNEE aaaaaa. SHOULDER ARTHROSCOPY bbbbbb. SHOULDER ARTHROSCOPY PK cccccc. LUMBAR LAMINECTOMY PACK dddddd. CRANIOTOMY PACK-LF eeeeee. OPEN SHOULDER PACK-LF ffffff. TOTAL HIP PACK-LF gggggg. TOTAL KNEE PACK-LF hhhhhh. SHOULDER ARTHROSCOPY PACK-LF iiiiii. EXTREMITY PACK jjjjjj. CLOSED HEART PEDS PACK kkkkkk. ORTHO MINOR PACK-LF llllll. FRACTURE TABLE PACK-LF mmmmmm. HAND - EDOC PACK-LF nnnnnn. FOOT LV - EDOC PACK-LF oooooo. SHOULDER - EDOC PACK-LF pppppp. FOOT ANKLE PACK-LF qqqqqq. OPEN HEART TRAY rrrrrr. SHOULDER PACK-LF ssssss. ROCKVILLE ASC EXTREMITY PACK tttttt. NEURO SPINE DRH PACK-LF uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF wwwwww. HAND AND FOOT PACK-LF xxxxxx. SPINE BUNDLE PACK yyyyyy. MINOR ORTHOPEDIC PACK-LF zzzzzz. FEM POP PACK-LF aaaaaaa. LAMINECTOMY PACK-LF bbbbbbb. CRANIOTOMY PACK-LF ccccccc. MAJOR ORTHO PACK-LF ddddddd. HAND WRIST PACK-LF eeeeeee. TOSH PODIATRY PACK-LF fffffff. TOTAL HIP ARTHROPLASTY PACK-LF ggggggg. TOSH UPPER EXTREM MIOSH PK-LF hhhhhhh. OPEN HEART CHILDRENS PACK-LF iiiiiii. CRANIOTOMY PACK-LF jjjjjjj. SPINE HARPER PACK-LF kkkkkkk. CRANIOTOMY

Z-1096-2023
Recall number
Z-1096-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
101,102 cases (227,538 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. SPINAL, Item Number: CDS780198O, Case UDI/GTIN: 40193489754101, Unit UDI/GTIN: 10193489754100, Lot Number: 22JBP283; b. SPINE CDS, Item Number: CDS780228D, Case UDI/GTIN: 40193489538329, Unit UDI/GTIN: 10193489538328, Lot Number: 22JMG559; c. TOTAL ORTHO CDS, Item Number: CDS940243K, Case UDI/GTIN: 40193489883443, Unit UDI/GTIN: 10193489883442, Lot Number: 22JBY480; d. TOTAL KNEE CDS, Item Number: CDS941144V, Case UDI/GTIN: 40195327132393, Unit UDI/GTIN: 10195327132392, Lot Number: 22JMG178; e. CDS HIP-LF, Item Number: CDS941183Q, Case UDI/GTIN: 40193489443449, Unit UDI/GTIN: 10193489443448, Lot Number: 22KMA031,22JMG560; f. KNEE TOTAL PACK-LF, Item Number: CDS941184Q, Case UDI/GTIN: 40193489444828, Unit UDI/GTIN: 10193489444827, Lot Number: 22JMB030; g. EXTREMITY CDS, Item Number: CDS941195L, Case UDI/GTIN: 40195327078271, Unit UDI/GTIN: 10195327078270, Lot Number: 22JBE513,22JBE512; h. SHOULDER ARTHRO CDS, Item Number: CDS941199M, Case UDI/GTIN: 40195327078295, Unit UDI/GTIN: 10195327078294, Lot Number: 22JBE580,22JBE558; i. GLENNON EXTREMITY CDS, Item Number: CDS941243P, Case UDI/GTIN: 40889942726487, Unit UDI/GTIN: 10889942726486, Lot Number: 22IBT784; j. KNEE ARTHROSCOPY, Item Number: CDS941418N, Case UDI/GTIN: 40889942702177, Unit UDI/GTIN: 10889942702176, Lot Number: 22JBD801; k. TOTAL KNEE, Item Number: CDS941419O, Case UDI/GTIN: 40193489754309, Unit UDI/GTIN: 10193489754308, Lot Number: 22IBT927,22IBO387; l. TOTAL HIP REPLACEMENT, Item Number: CDS941420P, Case UDI/GTIN: 40193489754415, Unit UDI/GTIN: 10193489754414, Lot Number: 22JBD759; m. TOTAL KNEE CDS-LF, Item Number: CDS941426AB, Case UDI/GTIN: 40195327026074, Unit UDI/GTIN: 10195327026073, Lot Number: 22JMF673,22JMC314; n. TOTAL SHOULDER CDS-LF, Item Number: CDS941428AD, Case UDI/GTIN: 40195327026098, Unit UDI/GTIN: 10195327026097, Lot Number: 22JMG619; o. TOTAL KNEE CDS-3, Item Number: CDS941432L, Case UDI/GTIN: 40889942500919, Unit UDI/GTIN: 10889942500918, Lot Number: 22KBE715,22KBB919; p. TOTAL HIP CDS-3, Item Number: CDS941433K, Case UDI/GTIN: 40889942500902, Unit UDI/GTIN: 10889942500901, Lot Number: 22KBE101,22KBE102; q. LOWER EXTREMITY CDS-LF, Item Number: CDS980666I, Case UDI/GTIN: 40193489485234, Unit UDI/GTIN: 10193489485233, Lot Number: 22JMA036; r. TOTAL HIP-LF, Item Number: CDS980788O, Case UDI/GTIN: 40193489233286, Unit UDI/GTIN: 10193489233285, Lot Number: 22JLA593,22ILB076; s. TOTAL HIP/KNEE CDS, Item Number: CDS981012D, Case UDI/GTIN: 40193489962247, Unit UDI/GTIN: 10193489962246, Lot Number: 22KBD744; t. SPINE PROCEDURE, Item Number: CDS981205O, Case UDI/GTIN: 40193489929127, Unit UDI/GTIN: 10193489929126, Lot Number: 22JMB556; u. OPEN HEART, Item Number: CDS981227M, Case UDI/GTIN: 40195327204601, Unit UDI/GTIN: 10195327204600, Lot Number: 22JLA237,22ILA229; v. LAMI, Item Number: CDS981886X, Case UDI/GTIN: 40195327145003, Unit UDI/GTIN: 10195327145002, Lot Number: 22JBE914; w. UPPER EXTREMITY CDS, Item Number: CDS981909W, Case UDI/GTIN: 40195327147632, Unit UDI/GTIN: 10195327147631, Lot Number: 22JBP170,22HBN600; x. LOWER EXTREMITY CDS, Item Number: CDS981910W, Case UDI/GTIN: 40195327144976, Unit UDI/GTIN: 10195327144975, Lot Number: 22JBP171,22HBL202,22HBL204; y. KNEE ARTHROSCOPY CDS, Item Number: CDS981924U, Case UDI/GTIN: 40193489969048, Unit UDI/GTIN: 10193489969047, Lot Number: 22JBV687; z. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS981975J, Case UDI/GTIN: 40193489743693, Unit UDI/GTIN: 10193489743692, Lot Number: 22JBR404; aa. SHOULDER CDS-LF, Item Number: CDS981979K, Case UDI/GTIN: 40193489741620, Unit UDI/GTIN: 10193489741629, Lot Number: 22JBR299; bb. PODIATRY CDS, Item Number: CDS982076J, Case UDI/GTIN: 40889942511496, Unit UDI/GTIN: 10889942511495, Lot Number: 22IBN424; cc. KNEE ARTHROSCOPY CDS, Item Number: CDS982198I, Case UDI/GTIN: 40193489332859, Unit UDI/GTIN: 10193489332858, Lot Number: 22KBC307,22JBU154; dd. SHOULDER ARTHROSCOPY CDS, Item Number: CDS982199I, Case UDI/GTIN: 40193489658768, Unit UDI/GTIN: 10193489658767, Lot Number: 22KBE697,22KBE110; ee. ACL CDS, Item Number: CDS982200I, Case UDI/GTIN: 40193489422598, Unit UDI/GTIN: 10193489422597, Lot Number: 22IBC928; ff. CRANIOTOMY CDS, Item Number: CDS982362F, Case UDI/GTIN: 40193489567770, Unit UDI/GTIN: 10193489567779, Lot Number: 22IBR032; gg. TOTAL KNEE CDS, Item Number: CDS982363K, Case UDI/GTIN: 40193489997232, Unit UDI/GTIN: 10193489997231, Lot Number: 22JBG335; hh. TOTAL KNEE, Item Number: CDS982370P, Case UDI/GTIN: 40195327141685, Unit UDI/GTIN: 10195327141684, Lot Number: 22JBA679; ii. TOTAL HIP CDS, Item Number: CDS982479L, Case UDI/GTIN: 40195327092352, Unit UDI/GTIN: 10195327092351, Lot Number: 22JMG180; jj. NEW LONDON TOTAL KNEE CDS, Item Number: CDS982519T, Case UDI/GTIN: 40195327247394, Unit UDI/GTIN: 10195327247393, Lot Number: 22KBB263; kk. TRAUMA CDS-LF, Item Number: CDS982601I, Case UDI/GTIN: 40193489345699, Unit UDI/GTIN: 10193489345698, Lot Number: 22JBL408,22IBR080; ll. TOTAL JOINT CDS, Item Number: CDS982753I, Case UDI/GTIN: 40195327110780, Unit UDI/GTIN: 10195327110789, Lot Number: 22JBH415; mm. CRANIOTOMY CDS-1, Item Number: CDS982889I, Case UDI/GTIN: 40889942208068, Unit UDI/GTIN: 10889942208067, Lot Number: 22ILA631; nn. SHOULDER CDS-1, Item Number: CDS982890F, Case UDI/GTIN: 40889942217695, Unit UDI/GTIN: 10889942217694, Lot Number: 22IBK480,22IBF030; oo. SPINE CDS-1, Item Number: CDS982894I, Case UDI/GTIN: 40889942207764, Unit UDI/GTIN: 10889942207763, Lot Number: 22JBH384; pp. TOTAL KNEE CDS-1, Item Number: CDS982897J, Case UDI/GTIN: 40889942798880, Unit UDI/GTIN: 10889942798889, Lot Number: 22KBA526; qq. TOTAL HIP CDS-1, Item Number: CDS982902I, Case UDI/GTIN: 40889942798897, Unit UDI/GTIN: 10889942798896, Lot Number: 22KBD147; rr. LOWER EXTREMITY CDS-2, Item Number: CDS982916F, Case UDI/GTIN: 40889942217404, Unit UDI/GTIN: 10889942217403, Lot Number: 22IBE697; ss. HAND CDS-2, Item Number: CDS982919G, Case UDI/GTIN: 40889942217381, Unit UDI/GTIN: 10889942217380, Lot Number: 22KBE812,22JBO966; tt. KNEE ARTHROSCOPY CDS-2, Item Number: CDS982920G, Case UDI/GTIN: 40889942217398, Unit UDI/GTIN: 10889942217397, Lot Number: 22JBW303,22JBA059; uu. HAND CDS, Item Number: CDS982940V, Case UDI/GTIN: 40193489965552, Unit UDI/GTIN: 10193489965551, Lot Number: 22JBJ049,22JBI496; vv. BACK CDS, Item Number: CDS982962A, Case UDI/GTIN: 40888277053374, Unit UDI/GTIN: 10888277053373, Lot Number: 22IBE730; ww. FRACTURE TABLE CDS, Item Number: CDS983092D, Case UDI/GTIN: 40889942934301, Unit UDI/GTIN: 10889942934300, Lot Number: 22JBH296,22IBE666; xx. ORTHO OP CDS, Item Number: CDS983097F, Case UDI/GTIN: 40193489203272, Unit UDI/GTIN: 10193489203271, Lot Number: 22JBP961,22JBC331; yy. ARTHROSCOPY CDS, Item Number: CDS983102G, Case UDI/GTIN: 40193489202350, Unit UDI/GTIN: 10193489202359, Lot Number: 22JBC332,22IBQ224; zz. ORTHO MINOR CDS, Item Number: CDS983106F, Case UDI/GTIN: 40195327052691, Unit UDI/GTIN: 10195327052690, Lot Number: 22JBE845,22IBN294; aaa. TOTAL JOINT KNEE CDS, Item Number: CDS983112I, Case UDI/GTIN: 40195327052707, Unit UDI/GTIN: 10195327052706, Lot Number: 22JBB873,22IBV963,22IBF742; bbb. TOTAL JOINT HIP CDS, Item Number: CDS983114I, Case UDI/GTIN: 40195327052592, Unit UDI/GTIN: 10195327052591, Lot Number: 22JBH597,22IBN141; ccc. SHOULDER CDS-LF, Item Number: CDS983132F, Case UDI/GTIN: 40195327148899, Unit UDI/GTIN: 10195327148898, Lot Number: 22JBJ092; ddd. ZALE CRANIOTOMY CDS, Item Number: CDS983188K, Case UDI/GTIN: 40195327105601, Unit UDI/GTIN: 10195327105600, Lot Number: 22JBQ370,22JBE497; eee. ZALE TOTAL KNEE CDS, Item Number: CDS983194K, Case UDI/GTIN: 40195327260829, Unit UDI/GTIN: 10195327260828, Lot Number: 22KBC319; fff. ZALE EXTREMITY CDS, Item Number: CDS983199I, Case UDI/GTIN: 40195327164622, Unit UDI/GTIN: 10195327164621, Lot Number: 22JBK516,22HBT364; ggg. OPEN SHOULDER CDS, Item Number: CDS983316D, Case UDI/GTIN: 40193489606448, Unit UDI/GTIN: 10193489606447, Lot Number: 22JBQ356,22JBP359; hhh. LOWER EXTREMITY CDS, Item Number: CDS983317D, Case UDI/GTIN: 40193489606578, Unit UDI/GTIN: 10193489606577, Lot Number: 22JBL404,22HBV156; iii. FHT TOTAL HIP, Item Number: CDS983344I, Case UDI/GTIN: 40193489932073, Unit UDI/GTIN: 10193489932072, Lot Number: 22JBH389; jjj. FHT TOTAL KNEE RPLCMNT, Item Number: CDS983345I, Case UDI/GTIN: 40193489455091, Unit UDI/GTIN: 10193489455090, Lot Number: 22JBJ857,22IBT650; kkk. TOTAL HIP CDS, Item Number: CDS983459J, Case UDI/GTIN: 40193489308601, Unit UDI/GTIN: 10193489308600, Lot Number: 22JBC460,22JBC966; lll. TOTAL KNEE CDS, Item Number: CDS983460K, Case UDI/GTIN: 40193489489935, Unit UDI/GTIN: 10193489489934, Lot Number: 22IBU730; mmm. CCOC ACL-LF, Item Number: CDS983562N, Case UDI/GTIN: 40193489907514, Unit UDI/GTIN: 10193489907513, Lot Number: 22IBO494; nnn. CCOC SPINAL FUSION, Item Number: CDS983566N, Case UDI/GTIN: 40193489907217, Unit UDI/GTIN: 10193489907216, Lot Number: 22JBL255; ooo. CCOC MAJOR EXTREMITY, Item Number: CDS983569L, Case UDI/GTIN: 40193489907583, Unit UDI/GTIN: 10193489907582, Lot Number: 22KBG390,22JBY621; ppp. EXTREMITY CDS, Item Number: CDS983609N, Case UDI/GTIN: 40195327209750, Unit UDI/GTIN: 10195327209759, Lot Number: 22KBE078,22KBE080; qqq. PODIATRY CDS, Item Number: CDS983610L, Case UDI/GTIN: 40195327210152, Unit UDI/GTIN: 10195327210151, Lot Number: 22JBP692; rrr. SHOULDER CDS, Item Number: CDS983613N, Case UDI/GTIN: 40195327210411, Unit UDI/GTIN: 10195327210410, Lot Number: 22KBA854,22JBK793; sss. DISTAL LEG CDS, Item Number: CDS983669J, Case UDI/GTIN: 40193489952491, Unit UDI/GTIN: 10193489952490, Lot Number: 22KBE716; ttt. HIP NAILING CDS, Item Number: CDS983676L, Case UDI/GTIN: 40195327118762, Unit UDI/GTIN: 10195327118761, Lot Number: 22JBH418; uuu. SHOULDER CDS, Item Number: CDS983688M, Case UDI/GTIN: 40195327045839, Unit UDI/GTIN: 10195327045838, Lot Number: 22JBJ581,22JBC446; vvv. TOTAL HIP CDS, Item Number: CDS983694N, Case UDI/GTIN: 40195327118779, Unit UDI/GTIN: 10195327118778, Lot Number: 22JBA175; www. UPPER EXTREMITY CDS, Item Number: CDS983696J, Case UDI/GTIN: 40193489954006, Unit UDI/GTIN: 10193489954005, Lot Number: 22KBC506; xxx. BASIC ORTHO CDS, Item Number: CDS983769K, Case UDI/GTIN: 40193489962612, Unit UDI/GTIN: 10193489962611, Lot Number: 22JBH900; yyy. TOTAL HIP PROCEDURE, Item Number: CDS983829M, Case UDI/GTIN: 40195327141753, Unit UDI/GTIN: 10195327141752, Lot Number: 22JMC801; zzz. TOTAL JOINT CDS-LF, Item Number: CDS983863D, Case UDI/GTIN: 40889942570981, Unit UDI/GTIN: 10889942570980, Lot Number: 22JDB465; aaaa. SHOULDER CDS-LF, Item Number: CDS983864C, Case UDI/GTIN: 40889942017639, Unit UDI/GTIN: 10889942017638, Lot Number: 22JDA646; bbbb. HAND CDS-LF, Item Number: CDS983873G, Case UDI/GTIN: 40193489401999, Unit UDI/GTIN: 10193489401998, Lot Number: 22JDA997,22HDB720; cccc. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS983874F, Case UDI/GTIN: 40889942017622, Unit UDI/GTIN: 10889942017621, Lot Number: 22JDA459; dddd. TOTAL JOINT, Item Number: CDS983903C, Case UDI/GTIN: 40193489773089, Unit UDI/GTIN: 10193489773088, Lot Number: 22JBV757,22IBT690; eeee. UPPER EXTREMITY CDS, Item Number: CDS983907L, Case UDI/GTIN: 40195327238347, Unit UDI/GTIN: 10195327238346, Lot Number: 22IBE813; ffff. LOWER EXTREMITY CDS, Item Number: CDS983909P, Case UDI/GTIN: 40195327238385, Unit UDI/GTIN: 10195327238384, Lot Number: 22JBB183; gggg. GENERAL ORTHO CDS, Item Number: CDS983915M, Case UDI/GTIN: 40195327238354, Unit UDI/GTIN: 10195327238353, Lot Number: 22KBI139,22IBC641; hhhh. ARTHROSCOPY CDS, Item Number: CDS983918L, Case UDI/GTIN: 40195327238392, Unit UDI/GTIN: 10195327238391, Lot Number: 22JBO944; iiii. KNEE ARTHROSCOPY CDS, Item Number: CDS983923K, Case UDI/GTIN: 40193489512268, Unit UDI/GTIN: 10193489512267, Lot Number: 22JMG515; jjjj. SHOULDER ARTHROSCOPY CDS, Item Number: CDS983935G, Case UDI/GTIN: 40193489425391, Unit UDI/GTIN: 10193489425390, Lot Number: 22JBO985; kkkk. KNEE ARTHROSCOPY CDS, Item Number: CDS983936I, Case UDI/GTIN: 40193489476096, Unit UDI/GTIN: 10193489476095, Lot Number: 22KBE763,22JBO932; llll. TOTAL ORTHO CDS, Item Number: CDS984019B, Case UDI/GTIN: 40195327191109, Unit UDI/GTIN: 10195327191108, Lot Number: 22KBC938; mmmm. GROTH LOWER EXTREMITY CDS, Item Number: CDS984188S, Case UDI/GTIN: 40195327252183, Unit UDI/GTIN: 10195327252182, Lot Number: 22JBO840; nnnn. HIP TOTAL PACK-ANTERIOR, Item Number: CDS984221I, Case UDI/GTIN: 40193489501897, Unit UDI/GTIN: 10193489501896, Lot Number: 22JMG520; oooo. PRAIRIE STAR SPINE CDS, Item Number: CDS984227B, Case UDI/GTIN: 40193489929134, Unit UDI/GTIN: 10193489929133, Lot Number: 22JBB520; pppp. 4TH FLOOR SHOULDER ARTHROSCOPY, Item Number: CDS984461L, Case UDI/GTIN: 40195327039036, Unit UDI/GTIN: 10195327039035, Lot Number: 22IBU706; qqqq. FOOT & ANKLE CDS-LF, Item Number: CDS984520J, Case UDI/GTIN: 40193489831390, Unit UDI/GTIN: 10193489831399, Lot Number: 22JDB120; rrrr. LAMI MICRODISC-LF, Item Number: CDS984527J, Case UDI/GTIN: 40193489831710, Unit UDI/GTIN: 10193489831719, Lot Number: 22IDC112,22IDB963; ssss. HIP PINNING CDS-LF, Item Number: CDS984528G, Case UDI/GTIN: 40193489831727, Unit UDI/GTIN: 10193489831726, Lot Number: 22JDC004,22IDA423,22HDB696; tttt. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS984530J, Case UDI/GTIN: 40193489831734, Unit UDI/GTIN: 10193489831733, Lot Number: 22KDA307,22IDA643; uuuu. UPPER EXTREMITY CDS-LF, Item Number: CDS984533I, Case UDI/GTIN: 40193489831956, Unit UDI/GTIN: 10193489831955, Lot Number: 22JDB905; vvvv. SPINE CDS-LF, Item Number: CDS984598G, Case UDI/GTIN: 40193489486132, Unit UDI/GTIN: 10193489486131, Lot Number: 22KMA677,22JMA043; wwww. SPINE CDS-LF, Item Number: CDS984611F, Case UDI/GTIN: 40889942719403, Unit UDI/GTIN: 10889942719402, Lot Number: 22JBH352; xxxx. LOWER EXTREMITY/ELBOW CDS, Item Number: CDS984631K, Case UDI/GTIN: 40195327070596, Unit UDI/GTIN: 10195327070595, Lot Number: 22JBJ969,22IBJ659,22IBJ660; yyyy. HAND CDS, Item Number: CDS984632I, Case UDI/GTIN: 40193489885980, Unit UDI/GTIN: 10193489885989, Lot Number: 22JBL295,22IBP803,22IBF627; zzzz. KNEE ARTHROSCOPY CDS, Item Number: CDS984633K, Case UDI/GTIN: 40195327070619, Unit UDI/GTIN: 10195327070618, Lot Number: 22JBH319; aaaaa. SPINE CDS, Item Number: CDS984634L, Case UDI/GTIN: 40195327070626, Unit UDI/GTIN: 10195327070625, Lot Number: 22JBH354,22JBA470,22HBU932; bbbbb. TOTAL HIP CDS, Item Number: CDS984652O, Case UDI/GTIN: 40193489433280, Unit UDI/GTIN: 10193489433289, Lot Number: 22JBE919; ccccc. KNEE ARTHROSCOPY CDS, Item Number: CDS984655N, Case UDI/GTIN: 40193489396165, Unit UDI/GTIN: 10193489396164, Lot Number: 22IBG368; ddddd. HAND CDS, Item Number: CDS984657J, Case UDI/GTIN: 40193489433259, Unit UDI/GTIN: 10193489433258, Lot Number: 22JBR377,22JBJ717,22IBV605; eeeee. TOTAL KNEE CDS-LF, Item Number: CDS984665I, Case UDI/GTIN: 40193489323796, Unit UDI/GTIN: 10193489323795, Lot Number: 22IBV346; fffff. SPINE MODULE CDS, Item Number: CDS984796L, Case UDI/GTIN: 40195327118786, Unit UDI/GTIN: 10195327118785, Lot Number: 22IBG139,22IBG140; ggggg. UPPER EXTREMITY CDS-LF, Item Number: CDS984855I, Case UDI/GTIN: 40195327104369, Unit UDI/GTIN: 10195327104368, Lot Number: 22JDA960; hhhhh. TOTAL JOINT CDS, Item Number: CDS985032K, Case UDI/GTIN: 40193489377881, Unit UDI/GTIN: 10193489377880, Lot Number: 22JMI136; iiiii. TOTAL JOINT CDS, Item Number: CDS985202B, Case UDI/GTIN: 40889942942054, Unit UDI/GTIN: 10889942942053, Lot Number: 22JBY728; jjjjj. ORTHO TRAUMA CDS, Item Number: CDS985210F, Case UDI/GTIN: 40195327110773, Unit UDI/GTIN: 10195327110772, Lot Number: 22IBC682; kkkkk. ACF CDS, Item Number: CDS985212D, Case UDI/GTIN: 40195327110742, Unit UDI/GTIN: 10195327110741, Lot Number: 22IBV336; lllll. CRANIOTOMY CDS, Item Number: CDS985213D, Case UDI/GTIN: 40195327110735, Unit UDI/GTIN: 10195327110734, Lot Number: 22IBB904,22IBB906; mmmmm. TOTAL JOINT CDS, Item Number: CDS985315D, Case UDI/GTIN: 40195327066933, Unit UDI/GTIN: 10195327066932, Lot Number: 22JBD670; nnnnn. ARTHROSCOPY CDS, Item Number: CDS985316A, Case UDI/GTIN: 40888277077554, Unit UDI/GTIN: 10888277077553, Lot Number: 22JBR384; ooooo. EXTREMITY CDS, Item Number: CDS985317B, Case UDI/GTIN: 40888277540980, Unit UDI/GTIN: 10888277540989, Lot Number: 22JBN999,22JBO001; ppppp. PODIATRY CDS, Item Number: CDS985319I, Case UDI/GTIN: 40195327091546, Unit UDI/GTIN: 10195327091545, Lot Number: 22JBL431,22JBH315; qqqqq. LAMINECTOMY CDS, Item Number: CDS985322O, Case UDI/GTIN: 40195327091485, Unit UDI/GTIN: 10195327091484, Lot Number: 22JBJ445; rrrrr. EXTREMITY CDS, Item Number: CDS985361B, Case UDI/GTIN: 40193489766654, Unit UDI/GTIN: 10193489766653, Lot Number: 22JBR386; sssss. TOTAL KNEE CDS, Item Number: CDS985394D, Case UDI/GTIN: 40193489262262, Unit UDI/GTIN: 10193489262261, Lot Number: 22HDB854; ttttt. TOTAL HIP CDS, Item Number: CDS985432M, Case UDI/GTIN: 40195327121946, Unit UDI/GTIN: 10195327121945, Lot Number: 22KBE794,22KBB899; uuuuu. TOTAL KNEE, Item Number: CDS985433L, Case UDI/GTIN: 40193489942959, Unit UDI/GTIN: 10193489942958, Lot Number: 22JBL792,22JBL794,22IBB924; vvvvv. ANTERIOR HIP, Item Number: CDS985463G, Case UDI/GTIN: 40195327092536, Unit UDI/GTIN: 10195327092535, Lot Number: 22JMH842; wwwww. HAND WRIST FOREARM, Item Number: CDS985543M, Case UDI/GTIN: 40193489900010, Unit UDI/GTIN: 10193489900019, Lot Number: 22IBT339,22IBE365; xxxxx. LOWER EXTREMITY, Item Number: CDS985546M, Case UDI/GTIN: 40193489943475, Unit UDI/GTIN: 10193489943474, Lot Number: 22HBL211,22HBL298; yyyyy. TOTAL HIP, Item Number: CDS985565Q, Case UDI/GTIN: 40193489468473, Unit UDI/GTIN: 10193489468472, Lot Number: 22IBE812,22HBW721; zzzzz. TOTAL KNEE, Item Number: CDS985566Q, Case UDI/GTIN: 40195327074419, Unit UDI/GTIN: 10195327074418, Lot Number: 22IBN723,22HBY438; aaaaaa. SHOULDER ARTHROSCOPY, Item Number: CDSOPP645P, Case UDI/GTIN: 40889942794639, Unit UDI/GTIN: 10889942794638, Lot Number: 22JBR883,22IBT596; bbbbbb. SHOULDER ARTHROSCOPY PK, Item Number: DYNJ00001M, Case UDI/GTIN: 40193489976565, Unit UDI/GTIN: 10193489976564, Lot Number: 22JBL005; cccccc. LUMBAR LAMINECTOMY PACK, Item Number: DYNJ00019G, Case UDI/GTIN: 40888277950567, Unit UDI/GTIN: 10888277950566, Lot Number: 22HBJ602; dddddd. CRANIOTOMY PACK-LF, Item Number: DYNJ0101292F, Case UDI/GTIN: 40193489434041, Unit UDI/GTIN: 10193489434040, Lot Number: 22IDA695; eeeeee. OPEN SHOULDER PACK-LF, Item Number: DYNJ0101293D, Case UDI/GTIN: 40193489345408, Unit UDI/GTIN: 10193489345407, Lot Number: 22JDA381; ffffff. TOTAL HIP PACK-LF, Item Number: DYNJ0101738F, Case UDI/GTIN: 40193489496148, Unit UDI/GTIN: 10193489496147, Lot Number: 22JDB848,22JDA228,22HDB757; gggggg. TOTAL KNEE PACK-LF, Item Number: DYNJ0101744F, Case UDI/GTIN: 40193489496100, Unit UDI/GTIN: 10193489496109, Lot Number: 22JDA738,22HDA698; hhhhhh. SHOULDER ARTHROSCOPY PACK-LF, Item Number: DYNJ0101759C, Case UDI/GTIN: 40193489855099, Unit UDI/GTIN: 10193489855098, Lot Number: 22JDA977; iiiiii. EXTREMITY PACK, Item Number: DYNJ01041N, Case UDI/GTIN: 40889942176237, Unit UDI/GTIN: 10889942176236, Lot Number: 22JDB724,22HDA765; jjjjjj. CLOSED HEART PEDS PACK, Item Number: DYNJ01043K, Case UDI/GTIN: 40889942864851, Unit UDI/GTIN: 10889942864850, Lot Number: 22IDA369; kkkkkk. ORTHO MINOR PACK-LF, Item Number: DYNJ0105549M, Case UDI/GTIN: 40889942853190, Unit UDI/GTIN: 10889942853199, Lot Number: 22HBG771; llllll. FRACTURE TABLE PACK-LF, Item Number: DYNJ0106852G, Case UDI/GTIN: 40889942854173, Unit UDI/GTIN: 10889942854172, Lot Number: 22IBH322; mmmmmm. HAND - EDOC PACK-LF, Item Number: DYNJ0111361O, Case UDI/GTIN: 40193489315708, Unit UDI/GTIN: 10193489315707, Lot Number: 22HMC671; nnnnnn. FOOT LV - EDOC PACK-LF, Item Number: DYNJ0111383L, Case UDI/GTIN: 40193489315715, Unit UDI/GTIN: 10193489315714, Lot Number: 22JMH166,22HMD255; oooooo. SHOULDER - EDOC PACK-LF, Item Number: DYNJ0111441L, Case UDI/GTIN: 40889942724766, Unit UDI/GTIN: 10889942724765, Lot Number: 22JMC960,22IMF441; pppppp. FOOT ANKLE PACK-LF, Item Number: DYNJ0111538B, Case UDI/GTIN: 40193489803199, Unit UDI/GTIN: 10193489803198, Lot Number: 22JMI063; qqqqqq. OPEN HEART TRAY, Item Number: DYNJ0115406K, Case UDI/GTIN: 40193489348072, Unit UDI/GTIN: 10193489348071, Lot Number: 22ILA263; rrrrrr. SHOULDER PACK-LF, Item Number: DYNJ0122428I, Case UDI/GTIN: 40889942854197, Unit UDI/GTIN: 10889942854196, Lot Number: 22HBJ059; ssssss. ROCKVILLE ASC EXTREMITY PACK, Item Number: DYNJ01466F, Case UDI/GTIN: 40888277573933, Unit UDI/GTIN: 10888277573932, Lot Number: 22JBW104; tttttt. NEURO SPINE DRH PACK-LF, Item Number: DYNJ0151196D, Case UDI/GTIN: 40193489213943, Unit UDI/GTIN: 10193489213942, Lot Number: 22IDC030; uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF, Item Number: DYNJ0151234D, Case UDI/GTIN: 40193489207430, Unit UDI/GTIN: 10193489207439, Lot Number: 22JDB045,22HDC207; vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF, Item Number: DYNJ0151255A, Case UDI/GTIN: 40889942245612, Unit UDI/GTIN: 10889942245611, Lot Number: 22IDA527; wwwwww. HAND AND FOOT PACK-LF, Item Number: DYNJ0151441F, Case UDI/GTIN: 40193489314343, Unit UDI/GTIN: 10193489314342, Lot Number: 22IDB677; xxxxxx. SPINE BUNDLE PACK, Item Number: DYNJ01592I, Case UDI/GTIN: 40888277071095, Unit UDI/GTIN: 10888277071094, Lot Number: 22JBS666; yyyyyy. MINOR ORTHOPEDIC PACK-LF, Item Number: DYNJ0159575B, Case UDI/GTIN: 40889942051435, Unit UDI/GTIN: 10889942051434, Lot Number: 22JDA481,22IDA304; zzzzzz. FEM POP PACK-LF, Item Number: DYNJ0159820F, Case UDI/GTIN: 40193489207058, Unit UDI/GTIN: 10193489207057, Lot Number: 22IDA027; aaaaaaa. LAMINECTOMY PACK-LF, Item Number: DYNJ0160146B, Case UDI/GTIN: 40889942051718, Unit UDI/GTIN: 10889942051717, Lot Number: 22JDA441,22JDA004; bbbbbbb. CRANIOTOMY PACK-LF, Item Number: DYNJ0160354B, Case UDI/GTIN: 40889942051817, Unit UDI/GTIN: 10889942051816, Lot Number: 22IDA086; ccccccc. MAJOR ORTHO PACK-LF, Item Number: DYNJ0160369A, Case UDI/GTIN: 40889942051824, Unit UDI/GTIN: 10889942051823, Lot Number: 22IDB989; ddddddd. HAND WRIST PACK-LF, Item Number: DYNJ0160535B, Case UDI/GTIN: 40889942051886, Unit UDI/GTIN: 10889942051885, Lot Number: 22JDB220; eeeeeee. TOSH PODIATRY PACK-LF, Item Number: DYNJ0161135A, Case UDI/GTIN: 40889942245575, Unit UDI/GTIN: 10889942245574, Lot Number: 22HDB934; fffffff. TOTAL HIP ARTHROPLASTY PACK-LF, Item Number: DYNJ0161140A, Case UDI/GTIN: 40889942245599, Unit UDI/GTIN: 10889942245598, Lot Number: 22JDB429; ggggggg. TOSH UPPER EXTREM MIOSH PK-LF, Item Number: DYNJ0161156A, Case UDI/GTIN: 40889942245582, Unit UDI/GTIN: 10889942245581, Lot Number: 22HDB938; hhhhhhh. OPEN HEART CHILDRENS PACK-LF, Item Number: DYNJ0161262B, Case UDI/GTIN: 40889942052173, Unit UDI/GTIN: 10889942052172, Lot Number: 22JDA240; iiiiiii. CRANIOTOMY PACK-LF, Item Number: DYNJ0161342B, Case UDI/GTIN: 40889942283768, Unit UDI/GTIN: 10889942283767, Lot Number: 22JDC155,22IDA323,22HDC435; jjjjjjj. SPINE HARPER PACK-LF, Item Number: DYNJ0162001D, Case UDI/GTIN: 40193489205542, Unit UDI/GTIN: 10193489205541, Lot Number: 22JDB967; kkkkkkk. CRANIOTOMY HARPER PACK-LF, Item Number: DYNJ0162022F, Case UDI/GTIN: 40195327019908, Unit UDI/GTIN: 10195327019907, Lot Number: 22IDA813,22IDA437; lllllll. ORTHO PACK-LF, Item Number: DYNJ0190129I, Case UDI/GTIN: 40193489357524, Unit UDI/GTIN: 10193489357523, Lot Number: 22JMH771,22IMF442,22HMC075; mmmmmmm. LOWER EXTREMITY PACK, Item Number: DYNJ01923I, Case UDI/GTIN: 40193489775571, Unit UDI/GTIN: 10193489775570, Lot Number: 22JBQ401,22IBI521,22HBP062; nnnnnnn. SHOULDER PACK, Item Number: DYNJ01927J, Case UDI/GTIN: 40193489775601, Unit UDI/GTIN: 10193489775600, Lot Number: 22JBC597,22HBV213; ooooooo. TOTAL KNEE PACK, Item Number: DYNJ01952G, Case UDI/GTIN: 40193489428507, Unit UDI/GTIN: 10193489428506, Lot Number: 22IME381; ppppppp. LAMINECTOMY PK, Item Number: DYNJ02379G, Case UDI/GTIN: 40193489229074, Unit UDI/GTIN: 10193489229073, Lot Number: 22JMC963,22IMH648,22IME562; qqqqqqq. UPPER EXTREMITY PACK, Item Number: DYNJ02464J, Case UDI/GTIN: 40193489854962, Unit UDI/GTIN: 10193489854961, Lot Number: 22KMA289,22HMB797; rrrrrrr. OPEN SHOULDER PACK, Item Number: DYNJ02465I, Case UDI/GTIN: 40193489855723, Unit UDI/GTIN: 10193489855722, Lot Number: 22IMB630; sssssss. LAMINECTOMY PACK, Item Number: DYNJ02468J, Case UDI/GTIN: 40193489855761, Unit UDI/GTIN: 10193489855760, Lot Number: 22JMG125; ttttttt. WATKINS SPINE PACK-LF, Item Number: DYNJ0275635L, Case UDI/GTIN: 40193489614122, Unit UDI/GTIN: 10193489614121, Lot Number: 22IMH375; uuuuuuu. ACL SUPPLEMENT PACK-LF, Item Number: DYNJ0287959L, Case UDI/GTIN: 40193489514095, Unit UDI/GTIN: 10193489514094, Lot Number: 22JMH423; vvvvvvv. TOTAL JOINT PACK, Item Number: DYNJ03170D, Case UDI/GTIN: 40888277745927, Unit UDI/GTIN: 10888277745926, Lot Number: 22HMG584; wwwwwww. HIP TOTAL PACK, Item Number: DYNJ03171D, Case UDI/GTIN: 40888277745934, Unit UDI/GTIN: 10888277745933, Lot Number: 22JMH862; xxxxxxx. CRANIOTOMY PACK-LF, Item Number: DYNJ0341030C, Case UDI/GTIN: 40193489735087, Unit UDI/GTIN: 10193489735086, Lot Number: 22HMF078; yyyyyyy. ORTHO MINOR PACK-LF, Item Number: DYNJ0350656C, Case UDI/GTIN: 40889942931850, Unit UDI/GTIN: 10889942931859, Lot Number: 22JDC171,22IDC110; zzzzzzz. TOTAL JOINT PACK-LF, Item Number: DYNJ0366371L, Case UDI/GTIN: 40889942964100, Unit UDI/GTIN: 10889942964109, Lot Number: 22IMC757; aaaaaaaa. SHOULDER ARTHROSCOPY PACK-LF, Item Number: DYNJ0367759L, Case UDI/GTIN: 40193489617352, Unit UDI/GTIN: 10193489617351, Lot Number: 22IMI089; bbbbbbbb. MINOR EXTREMITY PACK-LF, Item Number: DYNJ0367765I, Case UDI/GTIN: 40888277763327, Unit UDI/GTIN: 10888277763326, Lot Number: 22IMI064,22HMC119; cccccccc. TRAUMA PACK-LF, Item Number: DYNJ0369716L, Case UDI/GTIN: 40193489832496, Unit UDI/GTIN: 10193489832495, Lot Number: 22JMA812; dddddddd. TOTAL KNEE PACK-LF, Item Number: DYNJ0370463P, Case UDI/GTIN: 40889942493495, Unit UDI/GTIN: 10889942493494, Lot Number: 22IMH242,22IMH239; eeeeeeee. KNEE ARTHROSCOPY PACK-LF, Item Number: DYNJ0370478O, Case UDI/GTIN: 40889942493273, Unit UDI/GTIN: 10889942493272, Lot Number: 22JMA171; ffffffff. CRANIOTOMY PACK-LF, Item Number: DYNJ0370500P, Case UDI/GTIN: 40889942493020, Unit UDI/GTIN: 10889942493029, Lot Number: 22JMF181,22IMB632; gggggggg. ACF/LAMINECTOMY PACK-LF, Item Number: DYNJ0372759R, Case UDI/GTIN: 40195327021918, Unit UDI/GTIN: 10195327021917, Lot Number: 22IBM489; hhhhhhhh. OPEN HEART A & B PACK-LF, Item Number: DYNJ0373120AA, Case UDI/GTIN: 40193489907286, Unit UDI/GTIN: 10193489907285, Lot Number: 22IMH815,22IME212,22HME612; iiiiiiii. TOTAL HIP PACK-LF, Item Number: DYNJ0373136L, Case UDI/GTIN: 40193489325240, Unit UDI/GTIN: 10193489325249, Lot Number: 22JBT549,22JBO059,22IBL704; jjjjjjjj. MICRO DISC PACK-LF, Item Number: DYNJ0373199L, Case UDI/GTIN: 40193489324441, Unit UDI/GTIN: 10193489324440, Lot Number: 22JMB934; kkkkkkkk. TOTAL KNEE PACK-LF, Item Number: DYNJ0373200N, Case UDI/GTIN: 40193489325257, Unit UDI/GTIN: 10193489325256, Lot Number: 22IBM781,22IBJ522,22GBL023; llllllll. LUMBAR FUSION PACK-LF, Item Number: DYNJ0373264M, Case UDI/GTIN: 40193489325288, Unit UDI/GTIN: 10193489325287, Lot Number: 22IBF891; mmmmmmmm. HIP PACK-LF, Item Number: DYNJ0373860J, Case UDI/GTIN: 40889942481720, Unit UDI/GTIN: 10889942481729, Lot Number: 22IBO846; nnnnnnnn. ORTHO PACK-LF, Item Number: DYNJ0374003L, Case UDI/GTIN: 40889942902102, Unit UDI/GTIN: 10889942902101, Lot Number: 22IMD926; oooooooo. ARTHROSCOPY PACK-LF, Item Number: DYNJ0374018G, Case UDI/GTIN: 40193489556095, Unit UDI/GTIN: 10193489556094, Lot Number: 22JMD237; pppppppp. TOTAL HIP PACK-LF, Item Number: DYNJ0375811K, Case UDI/GTIN: 40888277763372, Unit UDI/GTIN: 10888277763371, Lot Number: 22IMI010,22IMI196; qqqqqqqq. OPEN HEART PACK, Item Number: DYNJ0376608O, Case UDI/GTIN: 40195327192052, Unit UDI/GTIN: 10195327192051, Lot Number: 22JMA708; rrrrrrrr. SPINE PACK-LF, Item Number: DYNJ0376635O, Case UDI/GTIN: 40193489793421, Unit UDI/GTIN: 10193489793420, Lot Number: 22JMH542,22IMF445; ssssssss. ARTHROSCOPY PACK-LF, Item Number: DYNJ0378266M, Case UDI/GTIN: 40195327089895, Unit UDI/GTIN: 10195327089894, Lot Number: 22IBM562; tttttttt. SPINAL PACK-LF, Item Number: DYNJ0378271P, Case UDI/GTIN: 40195327187935, Unit UDI/GTIN: 10195327187934, Lot Number: 22IBM571; uuuuuuuu. SHOULDER ARTHROSCOPY PACK-LF, Item Number: DYNJ0378474L, Case UDI/GTIN: 40889942062929, Unit UDI/GTIN: 10889942062928, Lot Number: 22JBF141; vvvvvvvv. HAND PACK-LF, Item Number: DYNJ0378681G, Case UDI/GTIN: 40889942434795, Unit UDI/GTIN: 10889942434794, Lot Number: 22JBY494,22JBD460; wwwwwwww. LUMBAR LAMINECTOMY PACK-LF, Item Number: DYNJ0378735F, Case UDI/GTIN: 40889942434740, Unit UDI/GTIN: 10889942434749, Lot Number: 22HMB798; xxxxxxxx. TOTAL HIP PACK-LF, Item Number: DYNJ0378756F, Case UDI/GTIN: 40889942434535, Unit UDI/GTIN: 10889942434534, Lot Number: 22JBQ425,22JBI485,22IMC760,22HMF033; yyyyyyyy. TOTAL KNEE PACK-LF, Item Number: DYNJ0378761D, Case UDI/GTIN: 40889942434542, Unit UDI/GTIN: 10889942434541, Lot Number: 22IBO873,22HMB799; zzzzzzzz. KNEE PACK-LF, Item Number: DYNJ0381475Q, Case UDI/GTIN: 40193489475303, Unit UDI/GTIN: 10193489475302, Lot Number: 22IBH850,22IBD330; aaaaaaaaa. BACK PACK-LF, Item Number: DYNJ0381507N, Case UDI/GTIN: 40193489475327, Unit UDI/GTIN: 10193489475326, Lot Number: 22IBF052,22IBF367; bbbbbbbbb. ARTHROSCOPY PACK-LF, Item Number: DYNJ0381513M, Case UDI/GTIN: 40193489475334, Unit UDI/GTIN: 10193489475333, Lot Number: 22JBW981; ccccccccc. HAND AND FOOT PACK-LF, Item Number: DYNJ0381560M, Case UDI/GTIN: 40889942452966, Unit UDI/GTIN: 10889942452965, Lot Number: 22JBV590,22HBS007; ddddddddd. SHOULDER ARTHROSCOPY PACK-LF, Item Number: DYNJ0381576N, Case UDI/GTIN: 40193489475273, Unit UDI/GTIN: 10193489475272, Lot Number: 22JBW977,22HBY918; eeeeeeeee. TOTAL KNEE PACK-LF, Item Number: DYNJ0382693L, Case UDI/GTIN: 40193489899284, Unit UDI/GTIN: 10193489899283, Lot Number: 22IMB635; fffffffff. TOTAL HIP PACK-LF, Item Number: DYNJ0382725M, Case UDI/GTIN: 40193489899277, Unit UDI/GTIN: 10193489899276, Lot Number: 22IBL750; ggggggggg. LAMINECTOMY PACK-LF, Item Number: DYNJ0382773N, Case UDI/GTIN: 40195327010592, Unit UDI/GTIN: 10195327010591, Lot Number: 22HBW100,22GBQ876; hhhhhhhhh. HAND PACK-LF, Item Number: DYNJ0386247AJ, Case UDI/GTIN: 40195327047406, Unit UDI/GTIN: 10195327047405, Lot Number: 22JMG695,22HMC076; iiiiiiiii. SHOULDER PACK-LF, Item Number: DYNJ0387727D, Case UDI/GTIN: 40889942898153, Unit UDI/GTIN: 10889942898152, Lot Number: 22JMA061; jjjjjjjjj. OPEN HEART PACK-LF, Item Number: DYNJ0392061O, Case UDI/GTIN: 40888277773487, Unit UDI/GTIN: 10888277773486, Lot Number: 22GME446; kkkkkkkkk. TOTAL HIP PACK-LF, Item Number: DYNJ0395001K, Case UDI/GTIN: 40889942387831, Unit UDI/GTIN: 10889942387830, Lot Number: 22JMG764,22IMB636; lllllllll. EXTREMITY PACK-LF, Item Number: DYNJ0395086J, Case UDI/GTIN: 40195327063680, Unit UDI/GTIN: 10195327063689, Lot Number: 22JMB053,22HMC673; mmmmmmmmm. ARTHROSCOPY SSC PACK-LF, Item Number: DYNJ0401259V, Case UDI/GTIN: 40195327206469, Unit UDI/GTIN: 10195327206468, Lot Number: 22IMH650; nnnnnnnnn. NEURO CRANI UNIV OF CIN PK-LF, Item Number: DYNJ0411273O, Case UDI/GTIN: 40193489372879, Unit UDI/GTIN: 10193489372878, Lot Number: 22IBG393; ooooooooo. CRANI PACK-LF, Item Number: DYNJ0415291J, Case UDI/GTIN: 40193489803175, Unit UDI/GTIN: 10193489803174, Lot Number: 22JLA419,22ILA039; ppppppppp. SPINAL FUSION PACK-LF, Item Number: DYNJ0415814L, Case UDI/GTIN: 40193489805254, Unit UDI/GTIN: 10193489805253, Lot Number: 22JMH874; qqqqqqqqq. MINOR SPINE PACK-LF, Item Number: DYNJ0415829K, Case UDI/GTIN: 40193489807180, Unit UDI/GTIN: 10193489807189, Lot Number: 22JMH037,22JMH042; rrrrrrrrr. SPITZER KNEE PACK, Item Number: DYNJ0415936L, Case UDI/GTIN: 40193489415729, Unit UDI/GTIN: 10193489415728, Lot Number: 22IME719; sssssssss. HAND PBMS PACK-LF, Item Number: DYNJ0421946J, Case UDI/GTIN: 40193489415927, Unit UDI/GTIN: 10193489415926, Lot Number: 22JMI064; ttttttttt. SPINE PACK-LF, Item Number: DYNJ0427330L, Case UDI/GTIN: 40889942160021, Unit UDI/GTIN: 10889942160020, Lot Number: 22JMF185; uuuuuuuuu. C-SECTION PACK-LF, Item Number: DYNJ04371I, Case UDI/GTIN: 40193489551687, Unit UDI/GTIN: 10193489551686, Lot Number: 22JMF186,22IMC762; vvvvvvvvv. HIP FRACTURE PACK, Item Number: DYNJ04375K, Case UDI/GTIN: 40193489551779, Unit UDI/GTIN: 10193489551778, Lot Number: 22HME513; wwwwwwwww. OPEN HEART PACK, Item Number: DYNJ04381J, Case UDI/GTIN: 40888277745156, Un

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

device · product 38 of 38

Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK

Z-1097-2023
Recall number
Z-1097-2023
Initiated
November 17, 2022
Classification
Class II
Status
Ongoing
Quantity
1,419 cases (4,349 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Code information

a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443; b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332; c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440; d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567; e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756; f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393; g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138; h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334; i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case UDI/GTIN: 40889942104803, Unit UDI/GTIN: 10889942104802, Lot Number: 22IBJ738; j. ARTHROSCOPY PACK-LF, Item Number: DYNJ15916C, Case UDI/GTIN: 40888277861610, Unit UDI/GTIN: 10888277861619, Lot Number: 22KBA679,22JBS955; k. ARTHROSCOPY BASIN PACK-LF, Item Number: DYNJ16633C, Case UDI/GTIN: 40888277858450, Unit UDI/GTIN: 10888277858459, Lot Number: 22JBV974; l. ARTHROTOMY PACK-LF, Item Number: DYNJ19751B, Case UDI/GTIN: 40884389018423, Unit UDI/GTIN: 10884389018422, Lot Number: 22IME726; m. ARTHROSCOPY PACK-LF, Item Number: DYNJ24861D, Case UDI/GTIN: 40888277545398, Unit UDI/GTIN: 10888277545397, Lot Number: 22JBJ980,22JBG368; n. ARTHROSCOPY PACK, Item Number: DYNJ26870I, Case UDI/GTIN: 40889942605669, Unit UDI/GTIN: 10889942605668, Lot Number: 22IBN707; o. ARTHROSCOPY PACK, Item Number: DYNJ30719C, Case UDI/GTIN: 40888277077745, Unit UDI/GTIN: 10888277077744, Lot Number: 22JBW329; p. ARTHROSCOPY PACK, Item Number: DYNJ31889C, Case UDI/GTIN: 40889942122777, Unit UDI/GTIN: 10889942122776, Lot Number: 22JBF800; q. ARTHROSCOPY PACK - LF, Item Number: DYNJ33193A, Case UDI/GTIN: 40884389363967, Unit UDI/GTIN: 10884389363966, Lot Number: 22IBD173; r. SC ARTHROSCOPY PACK, Item Number: DYNJ34330C, Case UDI/GTIN: 40889942577027, Unit UDI/GTIN: 10889942577026, Lot Number: 22IMD384; s. ARTHROSCOPY PACK-LF, Item Number: DYNJ34797I, Case UDI/GTIN: 40889942451693, Unit UDI/GTIN: 10889942451692, Lot Number: 22IMC421; t. ARTHROSCOPY PACK, Item Number: DYNJ35435C, Case UDI/GTIN: 40888277554697, Unit UDI/GTIN: 10888277554696, Lot Number: 22JBF703; u. ARTHROSCOPY PACK, Item Number: DYNJ35733F, Case UDI/GTIN: 40889942107866, Unit UDI/GTIN: 10889942107865, Lot Number: 22IBN489; v. ARTHROSCOPY PACK, Item Number: DYNJ36624D, Case UDI/GTIN: 40889942540304, Unit UDI/GTIN: 10889942540303, Lot Number: 22JBG374,22IBA906; w. OSC ARTHROSCOPY PK-LF, Item Number: DYNJ37381C, Case UDI/GTIN: 40889942292210, Unit UDI/GTIN: 10889942292219, Lot Number: 22JBY499,22JBB033,22HBY104; x. ARTHROSCOPY PACK, Item Number: DYNJ40334, Case UDI/GTIN: 40884389852737, Unit UDI/GTIN: 10884389852736, Lot Number: 22JBK330; y. ARTHROSCOPY PACK, Item Number: DYNJ42208B, Case UDI/GTIN: 40888277744142, Unit UDI/GTIN: 10888277744141, Lot Number: 22JBP189; z. ARTHROSCOPY PACK, Item Number: DYNJ45173D, Case UDI/GTIN: 40889942485223, Unit UDI/GTIN: 10889942485222, Lot Number: 22JBG783; aa. ARTHROSCOPY PACK, Item Number: DYNJ45340B, Case UDI/GTIN: 40889942120605, Unit UDI/GTIN: 10889942120604, Lot Number: 22IBL202; bb. ARTHROSCOPY PACK, Item Number: DYNJ47103C, Case UDI/GTIN: 40889942489177, Unit UDI/GTIN: 10889942489176, Lot Number: 22JMH577,22IME064; cc. KNEE ARTHROSCOPY PACK, Item Number: DYNJ48572, Case UDI/GTIN: 40888277913890, Unit UDI/GTIN: 10888277913899, Lot Number: 22JBH940; dd. KNEE ARTHROSCOPY PACK, Item Number: DYNJ50120D, Case UDI/GTIN: 40195327195657, Unit UDI/GTIN: 10195327195656, Lot Number: 22JBG571; ee. SHOULDER ARTHROSCOPY PACK, Item Number: DYNJ50126D, Case UDI/GTIN: 40195327212170, Unit UDI/GTIN: 10195327212179, Lot Number: 22JBG572,22IBD245; ff. SHOULDER ARTHROSCOPY, Item Number: DYNJ51381, Case UDI/GTIN: 40889942161325, Unit UDI/GTIN: 10889942161324, Lot Number: 22JBG797; gg. ARTHROSCOPY PACK, Item Number: DYNJ52778A, Case UDI/GTIN: 40889942638117, Unit UDI/GTIN: 10889942638116, Lot Number: 22HMC946; hh. ARTHROSCOPY PACK, Item Number: DYNJ52813, Case UDI/GTIN: 40889942328926, Unit UDI/GTIN: 10889942328925, Lot Number: 22JBD518; ii. ARTHROSCOPY PACK, Item Number: DYNJ56088A, Case UDI/GTIN: 40888277762900, Unit UDI/GTIN: 10888277762909, Lot Number: 22JBW279,22HBR114; jj. ARTHROSCOPY PACK, Item Number: DYNJ57151, Case UDI/GTIN: 40889942721901, Unit UDI/GTIN: 10889942721900, Lot Number: 22JBI446; kk. ARTHROSCOPY PACK, Item Number: DYNJ57741, Case UDI/GTIN: 40889942773672, Unit UDI/GTIN: 10889942773671, Lot Number: 22JBD988; ll. ARTHROSCOPY PACK-LF, Item Number: DYNJ58470, Case UDI/GTIN: 40889942856030, Unit UDI/GTIN: 10889942856039, Lot Number: 22JBT149,22IBU283; mm. ARTHROSCOPY KNEE, Item Number: DYNJ68081B, Case UDI/GTIN: 40195327199853, Unit UDI/GTIN: 10195327199852, Lot Number: 22IBN483; nn. ARTHROSCOPY PACK, Item Number: DYNJ82486, Case UDI/GTIN: 40195327197422, Unit UDI/GTIN: 10195327197421, Lot Number: 22HBT060; oo. HIP ARTHROSCOPY PACK, Item Number: DYNJ82503, Case UDI/GTIN: 40195327197378, Unit UDI/GTIN: 10195327197377, Lot Number: 22HBL505; pp. ARTHROSCOPY PACK, Item Number: DYNJ82546, Case UDI/GTIN: 40195327197927, Unit UDI/GTIN: 10195327197926, Lot Number: 22HBV066; qq. MG NS KNEE ARTHROSCOPY PACK, Item Number: DYNJ82585, Case UDI/GTIN: 40195327198764, Unit UDI/GTIN: 10195327198763, Lot Number: 22IBE887; rr. KNEE ARTHROSCOPY PACK, Item Number: DYNJ82630, Case UDI/GTIN: 40195327199525, Unit UDI/GTIN: 10195327199524, Lot Number: 22JBE442; ss. ARTHROSCOPY PACK, Item Number: DYNJ82707, Case UDI/GTIN: 40195327202317, Unit UDI/GTIN: 10195327202316, Lot Number: 22JMH335,22JMF855; tt. ARTHROSCOPY-LF, Item Number: DYNJ903247B, Case UDI/GTIN: 40889942754664, Unit UDI/GTIN: 10889942754663, Lot Number: 22JBQ059; uu. ARTHROSCOPY KIT, Item Number: DYNJ904304G, Case UDI/GTIN: 40195327209316, Unit UDI/GTIN: 10195327209315, Lot Number: 22JBR652,22IBT829; vv. SHOULDER ARTHROSCOPY, Item Number: DYNJ908907, Case UDI/GTIN: 40195327215577, Unit UDI/GTIN: 10195327215576, Lot Number: 22JBJ375; ww. KNEE ARTHROSCOPY, Item Number: DYNJ908920, Case UDI/GTIN: 40195327215874, Unit UDI/GTIN: 10195327215873, Lot Number: 22JBA830; xx. ARTHROSCOPY PACK, Item Number: DYNJHS0101I, Case UDI/GTIN: 40888277046413, Unit UDI/GTIN: 10888277046412, Lot Number: 22IBK139

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.