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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93800

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

Open FDA event record

Event summary

Timeline bucket
November 15, 2023
Product types
Device
Classifications
Class I
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

49 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 49

MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511

Z-1090-2024
Recall number
Z-1090-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
385028 trays

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 40888277597922 (case), 10888277597921 (unit), Lot Numbers: 22DBO136, 22EBE146, 22HBP422, 22IBN508, 22IBS920, 22KBS241, 23BBE594, 23CBN979, 23EBT594, 23IBA884

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 2 of 49

MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482

Z-1091-2024
Recall number
Z-1091-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
2683387 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNDJ1129, UDI/DI 40195327391400 (case), 10195327391409 (unit), Lot Numbers: 23EBD895, 23EBD896, 23EBD897, 23GBQ880; b) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23ABA019, 23EBM580, 23HBU078; c) REF DYNDA1893A, UDI/DI 40193489866125 (case), 10193489866124 (unit), Lot Numbers: 23CBA077, 23CBI537, 23CBT627, 23DBF373, 23EBM582, 23HBV368, 23JBP946; d) REF DYNDA1482, UDI/DI 40889942131151 (case), 10889942131150 (unit), Lot Numbers: 2022040690, 2022052390, 2022102090, 2023011790

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 3 of 49

MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH

Z-1092-2024
Recall number
Z-1092-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
385028 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYND41470SA, UDI/DI 40884389338705 (case), 10884389338704 (unit), Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; REF DYND41470SAH; UDI/DI - same as DYND41470SA, Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; b) REF DYNDA1931B, UDI/DI 40195327277360 (case), 10195327277369 (unit), Lot Numbers: 22LMC118, 22LMC126, 23EMB086; REF DYNDA1931BH, UDI/DI - same as DYNDA1931B, Lot Numbers: 22LMC118, 22LMC126, 23EMB086

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 4 of 49

MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A

Z-1093-2024
Recall number
Z-1093-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 2022022550, 2022050550, 2022051050

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 5 of 49

MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995

Z-1094-2024
Recall number
Z-1094-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 20193489190509 (case), 10193489190502 (unit), Lot Numbers: 2022050650

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 6 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D

Z-1095-2024
Recall number
Z-1095-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
385028 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF CDS840228F, UDI/DI 40889942778547 (case), 10889942778546 (unit), Lot Numbers: 22CLA155, 22FLA788, 22GLA774, 22KLB047, 23CLA672, 23CLA832, 23ELA032, 23FLA055, 23FLA663; b) REF DYNDC2128B, UDI/DI 40195327249114 (case), 10195327249113 (unit), Lot Numbers: 22IBG388; c) REF DYNJ44087A, UDI/DI 40889942561804 (case), 10889942561803 (unit), Lot Numbers: 21112457, 22022812, 22022812, 22022812, 22094063, 22104208, 22032993, 21112457, 22104208; d) REF DYNJ0352159C, UDI/DI 40889942622581 (case), 10889942622580 (unit), Lot Numbers: 22FBH338, 22OBE815; REF DYNJ0352159D, UDI/DI 40195327196616 (case), 10195327196615 (unit), Lot Numbers: 23AME808, 23EMI159, 23FME004, 23JMJ796

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 7 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYNDC3184, g) IMPLANTED VASCULAR ACCESS, REF DYNDC2842, h) INFANT COARTATION PACK, REF DYNJ54822D, i) INFANT OPEN HEART PUMP, REF DYNJ904068D, j) INFUSA PORT DRESSING KIT, REF DYNDC3192, k) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165, l) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B, m) OPEN HEART ACCESSORY CDS, REF CDS984289K, n) PACEMAKER PK SHSC-LF, REF DYNJ46785C, o) PERICARDIAL KIT, REF DYNDA2212B, p) PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B, q) PUH PERCUTANEOUS ECMO, REF DYNJ907554A, r) PUH PERCUTANEOUS ECMO, REF DYNJ907554C

Z-1096-2024
Recall number
Z-1096-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNDC3106, UDI/DI 40193489913270 (case), 10193489913279 (unit), Lot Numbers: 21LBT706, 22CBE273; b) REF DYKE1346D, UDI/DI 40195327114085 (case), 10195327114084 (unit), Lot Numbers: 22GBO510, 23BBG861, 23CBM313, 23EBN617, 23FBU655, 23GBR877, 23IBH963; c) REF DYKE1892A, UDI/DI 40195327430963 (case), 10195327430962 (unit), Lot Numbers: 10195327430962; d) REF DYKE1648G, UDI/DI 40195327007127 (case), 10195327007126 (unit), Lot Numbers: 22BBY253, 22DBG793, 22EBM485, 22GBY046, 22JBQ585, 22LBJ398, 23CBG974; e) REF DYKE1648I, UDI/DI 40195327351541 (case), 10195327351540 (unit), Lot Numbers: DYKE1648I; f) REF DYNDC3184, UDI/DI 40195327034093 (case), 10195327034092 (unit), Lot Numbers: DYNDC3184; g) REF DYNDC2842, UDI/DI 40193489342568 (case), 10193489342567 (unit), Lot Numbers: DYNDC2842; h) REF DYNJ54822D, UDI/DI 40195327151813 (case), 10195327151812 (unit), Lot Numbers: i) REF DYNJ904068D, UDI/DI 22DMI181, 22GMH542, 23FMG372, 23GMC127; j) REF DYNDC3192, UDI/DI 40195327153251 (case), 10195327153250 (unit), Lot Numbers: 23BMF718, 23CME669, 23FMJ514, 23GMH712, 23IMA898; k) REF DM1165, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: DYNDC3192; l) REF DM1165B, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: 23BBA069, 23CBR900, 23DBR127, 23EBP048, 23GBF718, 23HBN448, 23JBB725, 23JBP425; m) REF CDS984289K, UDI/DI 40195327067244 (case), 10195327067243 (unit), Lot Numbers: 22FBX071, 22JBT625, 22LBQ630, 22OBI364, 23ABP719, 23CBI370, 23FBP065, 23FBV540; n) REF DYNJ46785C, UDI/DI 40888277789389 (case), 10888277789388 (unit), Lot Numbers: 22CBY383, 22HBI240, 22JBS870, 22LBR066, 23ABC131, 23BBJ268, 23BBK356, 23CBS913; o) REF DYNDA2212B, UDI/DI 20193489197386 (case), 10193489197389 (unit), Lot Numbers: 22ILA769, 22LLA799, 23BLB093, 23ELA493; p) REF DYNJ44087B, UDI/DI 40195327346585 (case), 10195327346584 (unit), Lot Numbers: 23BBR837, 23EBF536, 23FBL664, 23HBQ739, 23IBF826, 23JBR527, 23KBA577; q) REF DYNJ907554A, UDI/DI 40195327024636 (case), 10195327024635 (unit), Lot Numbers: DYNJ907554A; r) REF DYNJ907554C, UDI/DI 40195327183838 (case), 10195327183837 (unit), Lot Numbers: 22IBF009, 22IBF810, 23ABS408, 23DBE286

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 8 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK, REF CVI4720A; l) CVC INSERTION PACK, REF CVI4720AH; m) DERM SURG CUSTOM PACK, REF DYNDA1584C; n) ER CENTRAL LINE KIT, REF P155508D; o) FISTULA GRAFT KIT, REF DT20345A; p) IMPLANTED PORT ACCESS, REF DYNDC2765B; q) IVAD KIT, REF DYNDC2004B; r) KIT LINE INSERTION, REF CVI4730H; s) KIT LINE INSERTION, REF CVI4730; t) LINE CHANGE KIT, REF DYNDC2927A; u) MAX BARRIER PACK, REF DYNJ50717; v) MEDIPORT W/CHG, REF DYNDC2219B; w) MEDIPORT W/CHG, REF DYNDC2219BH; x) NICU PICC INSERTION KIT, REF CVI4395B; y) PACK,CENTRAL LINE, REF DYNJ906907B; z) PEDI CENTRAL LINE AND PORT ACC, REF DT19740A; aa) PEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636; bb) PEDS/ NICU LINE KIT, REF MNS13555; cc) PICC LINE PACK, REF DYNJ64249A; dd) PICC LINE TRAY, REF DYNDC2170; ee) PORT ACCESS KIT, REF DYNDC3251; ff) PORT ACCESS KIT, REF DYNDC3251H; gg) PORT ACCESS KIT, REF DYNDC3252; hh) PORT ACCESS SUPPLIES, REF DYNDA2142B; ii) PORT ACCESS TRAY, REF DYNDC2449B; jj) PORT ACCESS TRAY, REF DYNDC3066; kk) PORT ACCESS TRAY, REF DYNDC3103; ll) PORT ACCESS/LAB KIT, REF DYNDC3129A; mm) PORT ACCESS/LAB KIT, REF DYNDC3129AH; nn) PORT FULL ACCESS TRAY, REF DT19330B; oo) PORT KIT, REF DT22785; pp) PORT KIT W/ HUBER NEEDLE, REF DT22780; qq) PORT-A-CATH ACCESS KIT, REF DYNDC1994C; rr) PORT-A-CATH ACCESS KIT, REF DYNDC1994D; ss) PORT-A-CATH ACCESS KIT, REF DYNDC1994DH; tt) SUBCLAVIAN PORT ACCESS, REF DYNDC2555C; uu) USG PIV INSERTION KIT, REF DYNDV2480; vv) USG PIV INSERTION KIT, REF DYNDV2480H; ww) VAD DRESSING CHANGE TRAY, REF DYNDC2078; xx) VAD DRESSING CHANGE TRAY, REF DYNDC2078H; yy) VAD DRESSING CHANGE TRAY, REF DYNDC2657A; zz) VAD KIT WITHOUT VALVES, REF DYNDC3179; aaa) VEIN CLOSURE PACK, REF DYNJ69976

Z-1097-2024
Recall number
Z-1097-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNJ65208A, UDI/DI 40195327120598 (case), 10195327120597 (unit), Lot Numbers: 23CMB532, 23CME753, 23EMD721, 23FMH948; b) REF DT22710, UDI/DI 40653160990636 (case), 10653160990635 (unit), Lot Numbers: c) REF DYNDC2002A, UDI/DI 21LBV542, 22CBM841, 22IBG132; d) REF DYNDC2723A, UDI/DI 40193489999236 (case), 10193489999235 (unit), Lot Numbers: 22ABH235, 22BBF113, 22IBG479; e) REF DYNDC2723B, UDI/DI 40195327007028 (case), 10195327004255 (unit), Lot Numbers: 22ABZ109, 22BBK108; f) REF CVI4805, UDI/DI 40195327068715 (case), 10195327068714 (unit), Lot Numbers: 22ABP582, 22CBP735, 22JBK237, 22LBK168; g) REF CVI4705, UDI/DI 40193489832373 (case), 10193489832372 (unit), Lot Numbers: 22CMF740, 22LMH493, 23BMA064, 23HMH653; h) REF DYNDC2721A, UDI/DI 40195327007080 (case), 10195327005313 (unit), Lot Numbers: 21LBK271, 22ABS686; i) REF DYNDC2721B, UDI/DI 40195327111091 (case), 10195327111090 (unit), Lot Numbers: 22CBS571, 22DBO302, 22IBG350; j) REF CVI4720, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23CLA574, 23DLA197; k) REF CVI4720A, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; l) REF CVI4720AH, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; m) REF DYNDA1584C, UDI/DI 40195327194506 (case), 10195327194505 (unit), Lot Numbers: 22HBB107, 22JBH444, 22KBN619, 22KBU753, 23ABH824, 23CBS036, 23EBD658, 23GBH542, 23IBI230; n) REF P155508D, UDI/DI 40193489899062 (case), 10193489899061 (unit), Lot Numbers: 22DMC487, 23AMB416, 23BMF491, 23FMD563; o) REF DT20345A, UDI/DI 40653160991565 (case), 10653160991564 (unit), Lot Numbers: 22ABJ804, 22BBA095, 22IBG184, 22OBE089; p) REF DYNDC2765B, UDI/DI 40195327039500 (case), 10195327039509 (unit), Lot Numbers: 22ABJ710, 22CBV307, 22CBX726, 22OBA248; q) REF DYNDC2004B, UDI/DI 40193489999335 (case), 10193489999334 (unit), Lot Numbers: 22ABH197, 22ABK671, 22BBE950, 22DBG182, 22GBD995; r) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; s) REF CVI4730H, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994, 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; t) REF DYNDC2927A, UDI/DI 40193489943420 (case), 10193489943429 (unit), Lot Numbers: 22BBW666, 22HBT170; u) REF DYNJ50717, UDI/DI 40889942032373 (case), 10889942032372 (unit), Lot Numbers: 22ABY200, 22HBH109; v) REF DYNDC2219B, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; w) REF DYNDC2219BH, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; x) REF CVI4395B, UDI/DI 40653160991633 (case), 10653160991632 (unit), Lot Numbers: 21LBV562, 22CBV268; y) REF DYNJ906907B, UDI/DI 40195327303526 (case), 10195327303525 (unit), Lot Numbers: 23BMF842; z) REF DT19740A, UDI/DI 40653160992524 (case), 10653160992523 (unit), Lot Numbers: 22EBE126, 22HBC049, 22IBG224; aa) REF DYNDH1636, UDI/DI 40193489934879 (case), 10193489934878 (unit), Lot Numbers: 22BBG415, 22DBE305, 22MBA761; bb) REF MNS13555, UDI/DI 40653160991954 (case). 10653160991953 (unit), Lot Numbers: 22CBE020, 22EBP942; cc) REF DYNJ64249A, UDI/DI 40193489381369 (case), 10193489381368 (unit), Lot Numbers: 22FLA161; dd) REF DYNDC2170, UDI/DI 40888277919100 (case), 10888277919099 (unit), Lot Numbers: 22HBO758, 22IBE630, 22LBP013, 23BBF471, 23BBL514, 23GBA859, 23JBD576; ee) REF DYNDC3251, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587; ff) REF DYNDC3251H, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587 gg) REF DYNDC3252, UDI/DI 40195327221141 (case), 10195327221140 (unit), Lot Numbers: 22IBG588; hh) REF DYNDA2142B, UDI/DI 40195327134168 (case), 10195327134167 (unit), Lot Numbers: 22DBG180, 22EMC030; ii) REF DYNDC2449B, UDI/DI 40195327010745 (case), 10195327010744 (unit), Lot Numbers: 21LBT939, 22EBP926, 22FBT224; jj) REF DYNDC3066, UDI/DI 40193489824644 (case), 10193489824643 (unit), Lot Numbers: 22CBD170; kk) REF DYNDC3103, UDI/DI 40193489962438 (case), 10193489962437 (unit), Lot Numbers: 22HBT222, 22IBG493, 22MBA063; ll) REF DYNDC3129A, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers: 22BBM598, 22CBZ667, 22DMC594, 22DME352; mm) REF DYNDC3129AH, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers: 22BBM598, 22CBZ667, 22DMC594, 22DME352; nn) REF DT19330B, UDI/DI 40653160992371 (case), 10653160992370 (unit), Lot Numbers: 22OBC582, 22OBE354; oo) REF DT22785, UDI/DI 40653160992326 (case), 10653160992325 (unit), Lot Numbers: 22CBP076, 22CBS504; pp) REF DT22780, UDI/DI 40653160992364 (case), 10653160992363 (unit), Lot Numbers: 22DBD209; qq) REF DYNDC1994C, UDI/DI 40195327083428 (case), 10195327083427 (unit), Lot Numbers: 22ABJ752, 22ABZ148, 22DBD308; rr) REF DYNDC1994D, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers: 22HBT161; ss) REF DYNDC1994DH, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers: 22HBT161; tt) REF DYNDC2555C, UDI/DI 40195327123421 (case), 10195327123420 (unit), Lot Numbers: 22OBE207; uu) REF DYNDV2480, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers: 22BMG253, 22CMF718, 22CMF720, 22GMB111; vv) REF DYNDV2480H, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers: 22BMG253, 22CMF718, 22CMF720, 22GMB111; ww) REF DYNDC2078, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers: 22EBV407, 22FBL375, 22GBF171; xx) REF DYNDC2078H, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers: 22EBV407, 22FBL375, 22GBF171; yy) REF DYNDC2657A, UDI/DI 40193489492973 (case), 10193489492972 (unit), Lot Numbers: 22FBU096, 22HBO094, 22IBT553, 23BBI094, 23EBD054, 23FBA804; zz) REF DYNDC3179, UDI/DI 40195327021444 (case), 10195327021443 (unit), Lot Numbers: 22ABK983, 22ABO532; aaa) REF DYNJ69976, UDI/DI 40195327000654 (case), 10195327001308 (unit), Lot Numbers: 22BBW440

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 9 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1808;

Z-1098-2024
Recall number
Z-1098-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNDH1679, UDI/DI 40653160991534 (case), 10195327007041 (unit), Lot Numbers: DYNDH1431A; b) REF DYNDH1664, UDI/DI 40193489993930 (case), 10193489993929 (unit), Lot Numbers: DYNDH1664; c) REF DYNDH1431A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: DYNDH1679; d) REF DYNJ46448, UDI/DI 40888277261465 (case), 10888277261464 (unit), Lot Numbers: 23ADA841; e) REF DYKE1520B, UDI/DI 40193489374958 (case), 10193489374957 (unit), Lot Numbers: 22ABB336, 22EBF090, 22FBF262, 22GBI072, 22HBE089, 22JBW122, 22OBH222, 23ABI623, 23BBL273, 23DBF391, 23FBJ442; f) REF DYNDH1808, UDI/DI 40195327264308 (case), 10195327264307 (unit), Lot Numbers: DYNDH1808, DYNDH1808, DYNDH1808

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 10 of 49

Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

Z-1099-2024
Recall number
Z-1099-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 00653160348477 (case), 10653160348474 (unit), Lot Numbers: 2022031480 2022041180

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 11 of 49

MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545

Z-1100-2024
Recall number
Z-1100-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 40889942214885 (case), 10889942214884 (unit), Lot Numbers: 22FMC728, 23CMB090

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 12 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ45175B; g) ENT PACK, REF DYNJ59030A; h) ENT PACK, REF DYNJ83416; i) ENT/EPISTAXIS TRAY, REF MNS2895; j) ENT/EPISTAXIS TRAY, REF MNS2895H; k) HEAD & NECK PACK, REF DYNJ60166C; l) HEAD AND NECK CDS, REF CDS983910K; m) HEAD AND NECK PACK, REF DYNJ68872C; n) HEAD AND NECK PACK, REF DYNJ46216J; o) NASAL, REF CDS984899G; p) NASAL, REF CDS984899I; q) PACK,BRONCHOSCOPY, REF DYNJ65475A; r) SINGLE CENTRAL LINE CAP CHANGE, REF DYNDC2213F; s) T & A, REF CDS984895I; t) T AND A, REF DYNJ36719C; u) T AND A, REF DYNJ906741B; v) T AND A CDS, REF CDS983362C; w) T&A PACK, REF DYNJ33112I; x) TONSIL CDS-LF, REF CDS980272L; y) TRACH CARE KIT, REF DYNDJN001A

Z-1101-2024
Recall number
Z-1101-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF CDS983682F; UDI/DI 40193489852975 (case), 10193489852974 (unit), lot Numbers: 22DDA235, 22GBJ113, 23ABQ437, 23EBS939; b) REF DYKE1718A; UDI/DI 40193489494656 (case), 10193489494655 (unit), Lot Numbers: 22FBU098, 22HBM601, 23ABM389; c) REF DYKE1718B; UDI/DI 40195327240128 (case), 10195327240127 (unit), Lot Numbers: 23DBE977; d) REF DYNDC2214G; UDI/DI 40195327051984 (case), 10195327051983 (unit), Lot Numbers: 22ABP471, 22BBO794, 22OBJ991; e) REF DYNJ55334C; UDI/DI 40889942703211 (case), 10889942703210 (unit), Lot Numbers: 22ABL051, 22EBV190, 22FBS394, 23BBA777, 23GBL169; f) REF DYNJ45175B; UDI/DI 40889942485216 (case), 10889942485215 (unit), Lot Numbers: 22CLB148, 22GLB002; g) REF DYNJ59030A; UDI/DI 40195327026203 (cases), 10195327026202 (unit), Lot Numbers: 22DBR838, 22EBO071, 22JBW765, 23FBF261, 23GBC456, 23HBR618; h) REF DYNJ83416; UDI/DI 40195327265053 (cases), 10195327265052 (unit), Lot Numbers: 22LBF471, 23ABN102, 23BBA471; i) REF MNS2895; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; j) REF MNS2895H; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; k) REF DYNJ60166C; UDI/DI 40193489467148 (case), 10193489467147 (unit), Lot Numbers: 23ELB099; l) REF CDS983910K; UDI/DI 40195327256594 (case), 10195327256593 (unit), Lot Numbers: 22JBT244, 23ABP271, 23ABP272, 23ABQ792, 23CBE912, 23DBR779, 23FBB371, 23JBL006, 23JBR337; m) REF DYNJ68872C; UDI/DI 40195327375714 (case), 10195327375713 (unit), Lot Numbers: 23DBC646, 23FBA039, 23GBA604, 23HBZ389, 23JBN556; n) REF DYNJ46216J; UDI/DI 40195327407491 (case), 10195327407490 (unit), Lot Numbers: 23EBF873, 23GBO919, 23GBT576, 23IBE145; o) REF CDS984899G; UDI/DI 40193489983822 (case), 10193489983821 (unit), Lot Numbers: 22CLA789; p) REF CDS984899I; UDI/DI 40195327313297 (case), 10195327313296 (unit), Lot Numbers: 23IBV180; q) REF DYNJ65475A; UDI/DI 40193489974578 (case), 10193489974577 (unit), Lot Numbers: 22DBF905; r) REF DYNDC2213F; UDI/DI 40195327052080 (case), 10195327052089 (unit), Lot number: 22ABM936, 22CMG684, 22EMB991; s) REF CDS984895I; UDI/DI 40193489983815 (case), 10193489983814 (unit), Lot Number: 22FBL382, 22IBD790, 23ABM451, 23DBM334; t) REF DYNJ36719C; UDI/DI 40193489265539 (case), 10193489265538 (unit), Lot Numbers: 21LBA818, 21LBU235, 22BBL912; u) REF DYNJ906741B; UDI/DI 40195327055364 (case), 10195327055363 (unit), Lot Numbers: 22ABF704, 22ABL214, 22BBQ966, 22FBY564, 22GBQ902, 22HMI302, 23AMA387, 23AMI317; v) REF CDS983362C; UDI/DI 40193489267342 (case), 10193489267341 (unit), Lot Numbers: 23ABI733; w) REF DYNJ33112I; UDI/DI 40193489402736 (case), 10193489402735 (unit), Lot Numbers: 22DBO140, 22DBO155, 22JBY668, 23BBT134, 23DBT051, 23EBA549, 23HBI328, 23IBM005; x) REF CDS980272L; UDI/DI 40193489616331 (case), 10193489616330 (unit), Lot Numbers: 22NBC732; y) REF DYNDJN001A; UDI/DI 40193489421614 (case), 10193489421613 (unit), Lot Numbers: 22EBB217, 22FBQ070, 22FBU496

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 13 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRIC CULTURE PACK, REF DYNJ53966AH; g) HERNIA, REF CDS982034R; h) HERNIA, REF CDS982034S; i) HERNIA PACK, REF DYNJ39331B; j) LAP APPY PACK, REF DYNJ37709J; k) LAP CHOLE CDS, REF CDS983912V; l) LAP CHOLE CDS, REF CDS983912W; m) LAP CHOLE CDS, REF CDS983912X; n) LAP CHOLE CDS, REF CDS983912Y; o) LAPAROSCOPY PACK, REF DYNJ41417J; p) LAPAROTOMY CDS-LF, REF CDS860091A; q) LOWER EXTREMITY, REF DYNJ46222M; r) MAJOR PACK, REF DYNJ80578A; s) MINOR PACK, REF DYNJ67217D; t) N L MINOR CDS, REF CDS982518O; u) N L MINOR CDS, REF CDS982518P; v) NON STERILE I&D KIT, REF DYKM1438; w) PACK,GU MINOR, REF DYNJ906885B; x) PLASTICS SUTURE TRAY, REF SUT13535; y) RESPIRATORY KIT, REF DYKM1404; z) TRACH CARE TRAY, REF DYNDJ1057A;

Z-1102-2024
Recall number
Z-1102-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
3297 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF CDS983673G, UDI/DI 40193489951746 (case), 10193489951745 (unit), Lot Numbers: 22EDA378, 22EDB208; b) REF CDS983673I, UDI/DI 40195327147335 (case), 10195327147334 (unit), Lot Numbers: 22GBJ096, 22GBJ097, 22HBR769, 22KBN934, 23ABH521, 23ABM586, 23BBR709, 23DBL344; c) REF DYKM1425, UDI/DI 40889942511236 (case), 10889942511235 (unit), Lot Numbers: 22DLA695, 22FLA284, 22GLA016, 22ILA012, 22ILA463, 22KLA336, 23ALA341, 23BLA132, 23DLB048, 23ELA454, 23FLA774, 23HLA165, 23ILB030, 23JLA435; d) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers: 23EBC489; e) REF DYNJ53966A, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181; f) REF DYNJ53966AH, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181, g) REF CDS982034R, UDI/DI 40195327003740 (case), 10195327003739 (unit), Lot Numbers: 21LBB488, 21LBC635, 22HBW422; h) REF CDS982034S, UDI/DI 40195327295364 (case), 10195327295363(unit), Lot Numbers: 23ABB710, 23BBA114, 23EBB482; i) REF DYNJ39331B, UDI/DI 40889942731580 (case), 10889942731589 (unit), Lot Numbers: 22HBH194, 22JBE708, 22LBL321, 23GBV891, 23IBA384; j) REF DYNJ37709J, UDI/DI 40193489376075 (case), 10193489376074 (unit), Lot Numbers: 22FMG179; k) REF CDS983912V, UDI/DI 40195327057146 (case), 10195327057145 (unit), Lot Numbers: 22BBX974, 22DBG451, 22DBO438, 22FBM809; l) REF CDS983912W, UDI/DI 40195327238408 (case), 10195327238407 (unit), Lot Numbers: 22KBI248, 23CBC518, 23DBM244; m) REF CDS983912X, UDI/DI 40195327403141 (case), 10195327403140 (unit), Lot Numbers: 23EBK644; n) REF CDS983912Y, UDI/DI 40195327417827 (case), 10195327417826 (unit), Lot Numbers: 23FBS625, 23HBD741, 23HBO315, 23IBC397, 23IBM310; o) REF DYNJ41417J, UDI/DI 40195327220991 (case), 10195327220990 (unit), Lot Numbers: 23FBQ267; p) REF CDS860091A, UDI/DI 40884389018324 (case), 10884389018323 (unit), Lot Numbers: 22ABW443, 22CBU907, 22FMA320, 22GMH940, 22IMI179, 22KMA029, 23AMJ550, 23CMF095, 23FMI870, 23GMF353; q) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23GBP791; r) REF DYNJ80578A, UDI/DI 40195327063819 (case), 10195327063818 (unit), Lot Numbers: 22FBO880; s) REF DYNJ67217D, UDI/DI 40195327278022 (case), 10195327278021 (unit), Lot Numbers: 23DBC699, 23EBB789, 23GBC854, 23GBP633; t) REF CDS982518O, UDI/DI 40195327247387 (case), 10195327247386 (unit), Lot Numbers: 23ABD137; u) REF CDS982518P, UDI/DI 40195327318858 (case), 10195327318857 (unit), Lot Numbers: 23BBM210; v) REF DYKM1438, UDI/DI 40889942529965 (case), 10889942529964 (unit), Lot Numbers: 22DDB583, 22FDA732, 22HDA409, 22JDA278, 22LDA778, 23BDB559, 23FDC186, 23IDA954; w) REF DYNJ906885B, UDI/DI 40193489972543 (case), 10193489972542 (unit), Lot Numbers: 22GBF087; x) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (case), Lot Numbers: 23GBD750; y) REF DYKM1404, UDI/DI 40889942473831 (case), 10889942473830 (unit), Lot Numbers: 22JBQ565, 23CBG138, 23EBO035, 23EBW986, 23GBP589; z) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23DBC974

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 14 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A

Z-1103-2024
Recall number
Z-1103-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
5969 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNJ904653G, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABE326; b) REF M101426, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD269; c) REF DYKE1387, UDI/DI 40889942384007 (case), 10889942384006 (unit), Lot Numbers: 22FBC677, 22FBU123, 22HBA432, 22JBG195, 23ABF156, 23BBE110, 23CBG139, 23CBU443; d) REF DYKE1364B, UDI/DI 40195327162734 (case), 10195327162733 (unit), Lot Numbers: 22FBV837, 22HBL534, 22IMH103, 22KMA408, 22LMG525; e) REF DYKE1892, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23ABD211, 23CBX144, 23FBN050; f) REF DYKE1648I, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX187; g) REF DYKM2222, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO502; h) REF CDS983912Y, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23FBO144 i) REF SUT13535, UDI/DI 40195327279951 (case), 10195327279950 (unit), Lot Numbers: 23CBX181; j) REF DYKE1930A, UDI/DI 40195327449224 (case), 10195327449223 (unit), Lot Numbers: 23FBR603, 23HBO128

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 15 of 49

MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939

Z-1104-2024
Recall number
Z-1104-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
18 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 40195327132492 (case), 10195327132491 (unit), Lot Numbers: 22GBO521

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 16 of 49

MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088

Z-1105-2024
Recall number
Z-1105-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
35 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 40193489884501 (case), 10193489884500 (unit), Lot Numbers: 21LBT672, 22BBG831

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 17 of 49

MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H

Z-1106-2024
Recall number
Z-1106-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
1184 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYKE1350D; UDI/DI 40193489339797 (case), 10193489339796 (unit), Lot Numbers: 22FBT089, 22LBN853, 23CBI535, 23DBQ149, 23EBI601; b) REF DYNJ36728C; UDI/DI 40193489265911 (case), 10193489265910 (unit), Lot Numbers: 22BBJ543, 22FBD924, 22HBR956, 23BBF230, 23FBG752; c) REF UVT1170; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696; d) REF UVT1170H; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 18 of 49

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

Z-1107-2024
Recall number
Z-1107-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
10391 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF MNS10750A, UDI/DI 00653160348286 (case), 10653160348283 (unit), Lot Numbers: 2022032150, 2022053150, 2022061750, 2022073050; b) REF DT21235A, UDI/DI 00653160348453 (case), 10653160348450 (unit), Lot Numbers: 2022012701; c) REF DYNDC3166A, UDI/DI 00653160350111 (case), 10653160350118 (unit), Lot Numbers: 2022021150, 2022031450, 2022031850

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 19 of 49

Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550

Z-1108-2024
Recall number
Z-1108-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
228 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 40884389740690 (case), 10884389740699 (unit), Lot Numbers: 22HBT075, 22IBF551, 23HBA140, 23IBO702

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 20 of 49

Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803

Z-1109-2024
Recall number
Z-1109-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
139 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNJ56344B, UDI/DI 40889942612322 (case), 10889942612321 (unit), Lot Numbers: 22CLA043, 22HLA191, 22ILA180, 23BLA030, 23BLB019, 23ELA630; b) REF DYNJ62803, UDI/DI 40193489688994 (case), 10193489688993 (unit), Lot Numbers: 22GBS133, 23GBF930

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 21 of 49

Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

Z-1110-2024
Recall number
Z-1110-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
2205 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 40884389599403 (case), 10884389599402 (unit), Lot Numbers: 22CBE151, 22FBR897, 22HBA156, 23ABA354

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 22 of 49

Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h) BRONCHOSCOPY TRAY, REF DYNDL1350A; i) BRONCHOSCOPY TRAY, REF DYNDL1350AH; j) CAP CHANGE LARGE KIT, REF DYNDA2277A; k) CAP CHANGE LARGE KIT, REF DYNDA2277B; l) DAILY VAD DRIVELINE KIT, REF DYNDC3006; m) DAILY VENT KIT, REF DYNDJ1076; n) DIALYSIS OFF KIT, REF DT21230A; o) DIALYSIS OFF KIT, REF DT20350B; p) DIALYSIS ON KIT, REF DT20355B; q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843; r) DR D CUSTOM PACK, REF DYNJ68068A; s) DR D CUSTOM PACK, REF DYNJ68068B; t) DUODENUM CULTURING PACK, REF DYNJ51294; u) EGD SOUTHEASTERN REG KIT, REF DYKE1830; v) EMERGENCY UMBILICAL INSERTION, REF UVT1165; w) ENDO KIT, REF DYKE1069B; x) ENDO KIT, REF DYKE1475B; y) ERCP ENDO KIT, REF P604360B; z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127; aa) FACIAL PLASTY PACK, REF DYNJ55335D; bb) FIRST YEAR KIT LF, REF EDUC1037; cc) FOLEY BULB INDUCTION KIT, REF MNS13545; dd) G BUNDLE CDS, REF CDS982759; ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B; ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C; gg) GENERAL/HERNIA PACK, REF DYNJ38541B; hh) GI BRONCHOSCOPY KIT, REF DYKE1254C; ii) HH CAR STOCK IN BIN, REF DYKM1883; jj) IMMERSION 4, REF EDUC05059A; kk) KIT LINE INSERTION, REF CVI4730; ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128; mm) LINE INSERT PACK, REF PHS422216004C; nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051; oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A; pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH; qq) MOHS KIT, REF DYNDA2072A; rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A; ss) N HOME CARE WOUND KIT, REF DYK1188079W; tt) NURSE KIT NO LOGO-LF, REF EDUC05036; uu) NURSE TOTE, REF DYKM1872A; vv) NURSING SKILLS, REF EDUC05015A; ww) PICC, REF CDS980470D; xx) PRE OP KIT, REF DYKS1262A; yy) PULMONARY SETUP KIT, REF DYNDA2648; zz) PULMONARY SETUP KIT, REF DYNDA2648H; aaa) REDDY JOINT BATH, REF MMJB001; bbb) REDDY JOINT BATH, REF MMJB001A; ccc) RNSG 1441, REF EDUC1029; ddd) RNSG 1441, REF EDUC1029H; eee) RNSG 2201, REF EDUC1034; fff) RNSG 2201, REF EDUC1034H; ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C; iii) SHORT TERM KIT, REF DYNDC3092; jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841; kkk) STERILE CAP CHANGE, REF DYNDA2387A; lll) STERILE PREP KIT, REF DYNDA1359; mmm) STERILE PREP KIT, REF DYNDA1359A; nnn) STRL EK SINGLE PACK, REF DYNDA1360B; ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A; ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019; qqq) SURGICAL PREP KIT, REF DYNJ46340B; rrr) SUTURE KIT, REF M101494; sss) SUTURE TRAY, REF DYNDS1085A; ttt) TRUNK KIT, REF DYKTRUNK1; uuu) TRUNK KIT 1EA, REF DYKM2013; vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011; www) URINALYSIS KIT, REF DYKM1251; xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B; yyy) VAD DRESSING KIT A, REF DYNDA2164; zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B; aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552; bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B; cccc) PORT ACCESS TRAY, REF DYNDC1128B;

Z-1111-2024
Recall number
Z-1111-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
26171 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNJ55960G, UDI/DI 40193489917827 (case), 10193489917826 (unit), Lot Numbers: 23ALA126; b) REF DYNJ53643C, UDI/DI 40889942615354 (case), 10889942615353 (unit), Lot Numbers: 22CLA226, 22ELA033, 22GLA633, 22JLA774, 23BLA613, 23ELA554, 23FLA005; c) REF DYKM1880, UDI/DI 40193489807524 (case), 10193489807523 (unit), Lot Numbers: 22FLA285, 23FLA657, 23HLA920; d) REF DYKE1601, UDI/DI 40889942956082 (case), 10889942956081 (unit), Lot Numbers: 23ABG889, 23BBN595, 23BBU202, 23FBA860, 23HBI592; e) REF DYNDH1242, UDI/DI 40889942598138 (case), 10889942598137 (unit), Lot Numbers: 22GLA574, 22KLA372, 22LLA696, 23ALA194, 23BLA985, 23CLA356, 23ELA844, 23FLA654, 23GLB027, 23HLA029, 23ILA700, 23JLB281; f) REF DYKE1840, UDI/DI 40195327105649 (case), 10195327105648 (unit), Lot Numbers: 22BBT072, 22EBU502, 22KBM213, 22LBH747; g) REF DYNJ37775F, UDI/DI 40888277906182 (case), 10888277906181 (unit), Lot Numbers: 22FDB681, 23ADC041, 23HDA605; h) REF DYNDL1350A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916; i) REF DYNDL1350AH, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916; j) REF DYNDA2277A, UDI/DI 40195327004423 (case), 10195327003944 (unit), Lot Numbers: 21LBS528, 22ABD844, 22BBE910; k) REF DYNDA2277B, UDI/DI UDI/DI 40195327120796 (case), 10195327120795 (unit), Lot Numbers: 22CBP893, 22DBQ630, 22IBG117; l) REF DYNDC3006, UDI/DI 40193489421256 (case), 10193489421255 (unit), Lot Numbers: 22EBO159; m) REF DYNDJ1076, UDI/DI 40889942790617 (Case), 10889942790616 (unit), Lot Numbers: 22IBS404, 23BBU808, 23FBQ938; n) REF DT21230A, UDI/DI 40653160991503 (case), 10653160991502 (unit), Lot Numbers: 21LBS504, 22ABZ147, 22CBX302, 22DBD319, 22HBU059, 22IBG323; o) REF DT20350B, UDI/DI 40653160991558 (case), 10653160991557 (unit), Lot Numbers; : 21LBT644, 22ABJ769, 22ABN465, 22ABU739, 22DBE295, 22GBD122, 22IBG207; p) REF DT20355B, UDI/DI 40653160991541 (case), 10653160991540 (unit), Lot Numbers: 22BBR313, 22DBG177, 22IBB820, 22IBG220; q) REF DYNDC2843, UDI/DI 40193489342575 (case), 10193489342574 (unit), Lot Numbers: 22ABB003, 22CBZ660, 22GBA430; r) REF DYNJ68068A, UDI/DI 40193489880190 (case), 10193489880199 (unit), Lot Numbers: 21LBS172, 21LBS192, 22DBE425, 22IBS035, 22KBR704, 22OBD030, 22OBD031; s) REF DYNJ68068B, UDI/DI 40195327306503 (case), 10195327306502 (unit), Lot Numbers: 23ABR366, 23CBT225, 23DBF157, 23HBI634, 23IBB018; t) REF DYNJ51294, UDI/DI 40889942148098 (case), 10889942148097 (unit), Lot Numbers: 22ABA731, 22ABU356, 22EBQ983, 23EBL823; u) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers: 22BLA237, 22BLA491, 22DLA830, 22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478; v) REF UVT1165, UDI/DI 40653160992319 (case), 10653160992318 (unit), Lot Numbers: 22EBE234, 22EBI596, 22OBD981; w) REF DYKE1069B, UDI/DI 40889942907169 (case), 10889942907168 (unit), Lot Numbers: 21LBJ553, 22ABO501, 23FBA549; x) REF DYKE1475B, UDI/DI 40889942893721 (case), 10889942893720 (unit), Lot Numbers: 22HDA831 y) REF P604360B, UDI/DI 10653160166382 (case), 00653160166385 (unit), Lot Numbers: 22KLA323, 22LLA144, 23ELB061; z) REF DYKM2127, UDI/DI 40195327045013 (case), 10195327045012 (unit), Lot Numbers: 22FLA082; aa) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers: 22EBM568, 22EBV274, 22LBP469, 23CBV507, 23DBT035, 23GBU056, 23JBR179; bb) REF EDUC1037, UDI/DI 40195327372331 (case), 10195327372330 (unit), Lot Numbers: 23DDA939, 23EDA052, 23EDB633; cc) REF MNS13545, UDI/DI 40653160991886 (case), 10653160991885 (unit), Lot Numbers: 21LBS695, 22CBE432, 22CBO137, 22OBC049; dd) REF CDS982759, UDI/DI 40884389451039 (case), 10884389451038 (unit), Lot Numbers: 22HBS221, 22KBB842, 22KBM294, 23DBL304, 23JBR357; ee) REF DYNDV2330B, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers: 21LBT031, 22OBL922; ff) REF DYNDV2330C, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers: 22OBL927; gg) REF DYNJ38541B, UDI/DI 40888277543974 (case), 10888277543973 (unit), Lot Numbers: 22FLA088, 22GLA360, 23CLA092, 23ELA016, 23FLA996; hh) REF DYKE1254C, UDI/DI 40889942782582 (case), 10889942782581 (unit), Lot Numbers: 22EDB717 ii) REF DYKM1883, UDI/DI 40193489234207 (case), 10193489234206 (unit), Lot Numbers: 22FBM572, 22FBR108, 22FBW122, 22HBF886; jj) REF EDUC05059A, UDI/DI 40195327203888 (case), 10195327203887 (unit), Lot Numbers: 23DLA805, 23ELA502, 23ELA556, 23ELB066, 23ELB153; kk) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994; ll) REF DYKM2128, UDI/DI 40195327045037 (case), 10195327045036 (unit), Lot Numbers: 22BLA697, 22CLA586. 22GLA027; mm) REF PHS422216004C, UDI/DI 10653160193081 (case), 00653160193084 (unit), Lot Numbers: 22OBG190, 22OBH215, 23EBS025, 23GBA226; nn) REF UROT1051, UDI/DI 40888277791764 (case), 10888277791763 (unit), Lot Numbers: 22BBA990, 22CBC606, 22DBQ612; oo) REF UROT1051A, UDI/DI40195327265992 (case), 10195327265991 (unit), Lot Numbers: 22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988; pp) REF UROT1051AH, UDI/DI 40195327265992 (case), 10195327265991 (unit), Lot Numbers: 22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988; qq) REF DYNDA2072A, UDI/DI 40193489586894 (case), 10193489586893 (unit). Lot Numbers: 22EBB022, 22FBN102, 22HBB085, 22KBG396, 22KBV529, 22LBJ527, 23EBC809, 23HBW281, 23IBR346; rr) REF DYNDA2390A, UDI/DI 40195327025671 (case), 10195327025670 (unit), Lot Numbers: 22MBA027; ss) REF DYK1188079W, UDI/DI 40080196854401 (case), 10080196854400 (unit), Lot Numbers: 22FBB386, 22HBU679, 22IBS684, 22LBD220, 23EBE385, 23FBJ776; tt) REF EDUC05036, UDI/DI 40193489846370 (case), 10193489846379 (unit), Lot Numbers: 22FLA555, 22KLA681, 23BLA125, 23BLA486, 23CLA375, 23CLA977, 23CLB254, 23DLA481, 23ELA396, 23FLA274, 23GLA325, 23HLA852, 23HLA997, 23JLA948, 23JLA949; uu) REF DYKM1872A, UDI/DI 40193489905404 (case), 10193489905403 (unit), Lot Numbers: 22IBV070, 22KBB323, 22KBE868, 23BBA791; vv) REF EDUC05015A, UDI/DI 40193489849036 (case), 10193489849035 (unit), Lot Numbers: 22FDB801, 22KDA995, 23FDB243; ww) REF CDS980470D, UDI/DI 40889942965046 (case), 10889942965045 (unit), Lot Numbers: 22IBU333; xx) REF DYKS1262A, UDI/DI 40193489481854 (case), 10193489481853 (unit), Lot Numbers: 22DMG419, 22EMH939, 22LMF533; yy) REF DYNDA2648, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers: 22GBO511, 22IBH087, 22JBI924; zz) REF DYNDA2648H, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers: 22GBO511, 22IBH087, 22JBI924; aaa) REF MMJB001, UDI/DI 40888277780553 (case), 10888277780552 (unit), Lot Numbers: 22DBO120, 22GBT358, 22JBV937, 22KBU083, 23ABL640, 23BBP851, 23DBD413; bbb) REF MMJB001A, UDI/DI 40195327514878 (case), 10195327514877 (unit), Lot Numbers: 23JBD137; ccc) REF EDUC1029, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers: 23CLA441, 23DLB129; ddd) REF EDUC1029H, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers: 23CLA441, 23DLB129; eee) REF EDUC1034, UDI/DI 40195327318940 (case) 10195327318949 (unit), Lot Numbers: 23CLA376; fff) REF EDUC1034H, UDI/DI 40195327318940 (case), 10195327318949 (unit), Lot Numbers: 23CLA376; ggg) REF DYNDC3185, UDI/DI 40195327034109 (case), 10195327034108 (unit), Lot Numbers: 23BBK719, 23CBM278, 23DBF310, 23DBN505, 23EBC880, 23EBU809; hhh) REF DYNDC1311C, UDI/DI 40080196151562 (case), 10080196151561 (unit), Lot Numbers: 22EBB019, 22IBB934, 23CBN984; iii) REF DYNDC3092, UDI/DI 40193489878500 (case), 10193489878509 (unit), Lot Numbers: 22ABZ049, 22HBS850, 22IBG383; jjj) REF DYNDC2841, UDI/DI 40193489364676 (case), 10193489364675 (unit), Lot Numbers: 22ABB008, 22CBX108, 22CBY133, 22CBZ300, 22DBP299, 22IBA926, 22IBG249; kkk) REF DYNDA2387A, UDI/DI 40195327025077 (case), 10195327025076 (unit), Lot Numbers: 22BBW633, 22DBD284, 22HBH277, 22IBI878; lll) REF DYNDA1359, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers: 22GBI645, 22IBP085, 22KBH590, 22KBV524; mmm) REF DYNDA1359A, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers: 23FBK812, 23FBP270, 23HBV043, 23IBN603; nnn) REF DYNDA1360B, UDI/DI 40889942903864 (case), 10889942903863 (unit), Lot Numbers: 22EBN763, 22KBN275, 23BBF919, 23EBR548, 23HBM494; ooo) REF DYNDC2768A, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABJ771, 22DBB123; ppp) REF DYNDT1019, UDI/DI 40080196954316 (case), 10080196954315 (unit), Lot Numbers: 22EBB037, 22GLA426, 22GLA485, 22HLA020, 22HLA318, 22HLA933; qqq) REF DYNJ46340B, UDI/DI 40193489267502 (case), 10193489267501 (unit), Lot Numbers: 22EBG807, 22JBI745, 22KBO369, 23BBC803, 23DBD059, 23GBT971, 23HBK037; rrr) REF M101494, UDI/DI 40193489215268 (case), 10193489215267 (unit), Lot Numbers: 22EBB001, 22FBW213, 22GBA533, 22IBH767, 22JBR552, 23ABH794, 23ABO157, 23BBD517, 23CBT240, 23DBS004, 23FBF076, 23GBW208; sss) REF DYNDS1085A, UDI/DI 40080196778692 (case), 10080196778690 (unit), Lot Numbers: 22GBD145, 22GBT473, 22HBW597, 22JBQ784, 22LBK199, 23DBF574, 23EBB065, 23FBI285; ttt) REF DYKTRUNK1, UDI/DI 40888277572196 (case), 10888277572195 (unit), Lot Numbers: 22IBB692, 22IBT561, 22KBN272, 22KBN273; uuu) REF DYKM2013, UDI/DI 40193489796583 (case), 10193489796582 (unit), Lot Numbers: 23ABB515, 23CBM980; vvv) REF DYNDA3011, UDI/DI 40195327283231 (case), 10195327283230 (unit), Lot Numbers: 23ABV484, 23BBS928, 23CBF143, 23CBP415; www) REF DYKM1251, UDI/DI 40889942146445 (case), 10889942146444 (unit), Lot Numbers: 22MBA574, 23JBO199; xxx) REF DYNDC2882B, UDI/DI 40193489417105 (case), 10193489417104 (unit), Lot Numbers: 22CBS826, 22IBG358, 22MBA772; yyy) REF DYNDA2164, UDI/DI 40889942789642 (case), 10889942789641 (unit), Lot Numbers: 22ABG432, 22ABU607, 22DBG204, 22IBG168, 22JBG542, 23ABC729, 23BBN712, 23CBM329, 23EBU380; zzz) REF DYNDH1342B, UDI/DI 20193489111900 (case), 10193489111903 (unit), Lot Numbers: 2022042580; aaaa) REF EBSI1552, UDI/DI 00653160352320 (case), 10653160352327 (unit), Lot Numbers: 2022061380; bbbb) REF DYNDC1712B, UDI/DI 40888277279415 (case), 10888277279414 (unit), Lot Numbers: 2022032180; cccc) REF DYNDC1128B, UDI/DI 40888277950802 (case), 10888277950801 (unit), Lot Numbers: 2022032850, 2022050450

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 23 of 49

Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A;

Z-1112-2024
Recall number
Z-1112-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
21154 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF SUT13935, UDI/DI 40193489440714 (case), 10193489440713 (unit), Lot Numbers: 23GBO782, 23GBP869, 23HBA879, 23HBX374; b) REF SUT21215, UDI/DI 653160325645 (case), 10653160325642 (unit), Lot Numbers: 22EBB078, 22FBE772, 22GBJ917, 22HBN681, 22HBW656, 22JBB835, 23ABL668, 23FBT868, 23GBK697, 23HBU987; c) REF SUT15380, UDI/DI 10653160203698 (case), 653160203691 (unit), Lot Numbers: 22EBI572, 22FBK706, 22GBI140, 22GBZ790, 22JBT097, 22KBW287, 22LBS262, 23DBB365, 23EBB439, 23EBS520, 23FBV416, 23HBV213; d) REF SUT19005, UDI/DI 653160271454 (case), 10653160271451 (unit), Lot Numbers: 23CBV894, 23EBM160, 23FBI594, 23GBK013, 23HBW722; e) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (unit), Lot Numbers: 22FBG265, 22FBU120, 22HBK650, 22LBS268, 23CBH315, 23EBH269, 23HBU983; f) REF UVT840A, UDI/DI 653160292008 (case), 10653160292005 (unit), Lot Numbers: 22ABH461, 22ABJ736; g) REF DYNDA2369A, UDI/DI 00653160352160 (case), 10653160352167 (unit), Lot Numbers: 2022051050, 2022072750; h) REF DYNDC2869B, UDI/DI 20193489111719 (case), 10193489111712 (unit), Lot Numbers: 2021121750, 2022010450; i) REF DT20900A, UDI/DI 00653160353211 (case), 10653160353218 (unit), Lot Numbers: 2022061380, 2022061480, 2022082280; j) REF DYNDA2660A, UDI/DI 00653160351897 (case), 10653160351894 (unit), Lot Numbers: 2022042580, 2022050280, 2022082280; k) REF DYNDH1650, UDI/DI 20193489110866 (case), 10193489110869 (unit), Lot Numbers: 2022012050; l) REF DYNDC2816C, UDI/DI 00653160348309 (case), 10653160348306 (unit), Lot Numbers: 2022041880; m) REF EBSI1302A, UDI/DI 20193489111894 (case), 10193489111897 (unit), Lot Numbers:2022020250, 2022022880, 2022082280; n) REF DYNDC3188, UDI/DI 00653160348828 (case), 10653160348825 (unit), Lot Numbers: 2022012450; o) REF DYNDA2659A, UDI/DI 00653160351880 (case), 10653160351887 (unit), Lot Numbers: 2022042850; p) REF DYNDS1085A, UDI/DI 40080196778691 (case), 10080196778690 (unit), Lot Numbers: 2022041150, 2022051350, 2022053150

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 24 of 49

Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445; f) NICU INSERTION & DRSG CHG TRAY, REF EBSI1306A; g) PIV BSI KIT, REF BSIPIV1010; h) ULTRASOUND GUIDED IV START KIT, REF DYNDV2465

Z-1113-2024
Recall number
Z-1113-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
3900 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNDA2863, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABQ171, 22ABT619, 22IBG373; b) REF DYNDA2863H, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABQ171, 22ABT619, 22IBG373; c) REF DYNDV2518, UDI/DI 40195327089079 (case), 10195327089078 (unit), Lot Numbers: 22GBA169, 22HBU208; d) REF DYNDV2518H, UDI/DI 40195327089079 (case), 10195327089078 (unit), Lot Numbers: 22GBA169, 22HBU208; e) REF DYNDV2445, UDI/DI 20193489110576 (case), 10193489110579 (unit), Lot Numbers: 2022012480; f) REF EBSI1306A, UDI/DI 00653160352122 (case), 10653160352129 (unit), Lot Numbers: 2022042850; g) REF BSIPIV1010, UDI/DI 00653160349153 (case), 10653160349150 (unit), Lot Numbers: 2022020750, 2022040480, 2022082980; h) REF DYNDV2465, UDI/DI 20193489110163 (case), 10193489110166 (unit), Lot Numbers: 2022031480, 2022041880

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 25 of 49

Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H

Z-1114-2024
Recall number
Z-1114-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
16 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNDA2936, UDI/DI 40195327132577 (case), 10195327132576 (unit), Lot Numbers: 22FBQ167; b) REF DYNDA2936H, UDI/DI 40195327132577 (case), 10195327132576 (unit), Lot Numbers: 22FBQ167

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 26 of 49

Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;

Z-1115-2024
Recall number
Z-1115-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNDV2183A, UDI/DI 40195327050710 (case), 10195327050719 (unit), Lot Numbers: 22ABT635, 22ABY152, 22BBO850; b) REF DYNDH1641A, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; c) REF DYNDH1641AH, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; d) REF DYNDH1719A, UDI/DI40889942880486 (case), 10889942880485 (unit), Lot Numbers: 23ABC589, 23ABR972, 23BBS014

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 27 of 49

Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A

Z-1116-2024
Recall number
Z-1116-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
1270 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNJ69664, UDI/DI 40193489966337 (case), 10193489966336 (unit), Lot Numbers: 21LBW095, 22EBT126, 22HBQ767, 22LBB063, 23EBF143; b) REF DYNJ81659A, UDI/DI 40195327277094 (case), 10195327277093 (unit), Lot Numbers: 22KBK040; c) REF DYKS1377, UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 22LLA282; d) REF DYKS1377A , UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 23BLA389

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 28 of 49

Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f) DRSG CHANGE TRAY W/ CHG, REF DT21460BH; g) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i) PEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j) PORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k) PORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l) PORT ACCESS PACK-LF, REF DYNJ0352159D; m) PORT DRESSING CHANGE KIT, REF DT22810; n) PORT DRESSING CHANGE TRAY, REF DT20640B; o) PORT DRESSING CHANGE TRAY, REF DYNDC3052A; p) PORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s) SALINE GAUZE DRESSING TRAY, REF DYNDA2937; t) SALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u) SALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v) ADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w) A-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x) CENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y) CENTRAL LINE DRESSING KIT, REF EBSI1088A; z) CENTRAL LINE DRESSING KIT, REF EBSI1088B; aa) CENTRAL LINE KIT, REF EBSI1245B; bb) CENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc) CVC DRESSING CHANGE KIT, REF EBSI1472A; dd) CVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee) CVL DRESSING CHANGE KIT, REF EBSI1547; ff) DIALYSIS CHANGE KIT, REF EBSI1453; gg) DIALYSIS KIT, REF EBSI1476; hh) DRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii) DRESSING CHANGE TRAY, REF EBSI1513; jj) EBSI DRESSING CHANGE KIT, REF EBSI1163B; kk) ERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll) ERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo) LARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp) OUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq) OUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr) PACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss) PICC DRESSING CHANGE KIT, REF EBSI1471A; tt) PICC DRESSING CHANGE TRAY, REF EBSI1512; uu) PICC DRESSING CHANGE TRAY, REF EBSI1546; vv) PICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww) PICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx) PORT ACCESS TRAY, REF DYNDC2703A; yy) PORT DRESSING CHANGE KIT, REF EBSI1434A; zz) PORT DRESSING CHANGE KIT, REF EBSI1525; aaa) PORT DRESSING CHANGE KIT, REF EBSI1525; bbb) PORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc) SMALL BORE DRESSING CHANGE KIT, REF EBSI1556

Z-1117-2024
Recall number
Z-1117-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
86699 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF CVI4705, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23FMD562; b) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers; 23BBJ923, 23CBB549, 23FBM548, 23GBF094, 23GBR827, 23HBM237; c) REF DYNDC3131A, UDI/DI 40195327105694 (case), 10195327105693 (unit), Lot Numbers: 22CBJ619, 22DBD254, 22IBG214; d) DT17405A, UDI/DI 40653160991619 (case), 10653160991618 (unit), Lot Numbers: 22CBY954, 22DBB495, 22DBH244, 22HBT273; e) DT21460B, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; f) DT21460BH, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; g) DM580, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; h) DM580H, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; i) DYNDC3120A, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME583, 23FMC905; j) DYNDC3081, UDI/DI 40193489849746 (case), 10193489849745 (unit), Lot Numbers: 22CBG508; k) DYNDC3080, UDI/DI 40193489849739 (case), 10193489849738 (unit), Lot Numbers: 22BBR416, 2EBD704; l) DYNJ0352159D, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME774; m) DT22810, UDI/DI 40653160993361 (case), 10653160993360 (unit), Lot Numbers: 22IBI823; n) DT20640B, UDI/DI 40653160991671 (case), 10653160991670 (unit), Lot Numbers: 22ABT093, 22JBB214; o) DYNDC3052A, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers: 22LMI145; p) DYNDC3052AH, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers:22LMI145; q) DYKM1528, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; r) DYKM1528H, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; s) DYNDA2937, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 22JBK727, 22JBT535, 23CBX574; t) DYNDA2937A, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers:23DBF619, 23EBK506, 23FBF438, 23HBN471, 23IBN607; u) DYNDA2937AH, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 23EBK506, 23FBF438, 23HBN471, 23IBN607 v) REF DYNDC3161, UDI/DI 20193489111627 (case), 10193489111620 (unit), Lot Numbers: 2022031480, 2022061380, 2022082980; w) REF EBSI1530, UDI/DI 00653160354195 (case), 10653160354192 (unit), Lot Numbers: 2022082280; x) REF EBSI1489, UDI/DI 20193489111238 (case), 10193489111231 (unit), Lot Numbers: 2022011350, 2022022880, 2022082280; y) REF EBSI1088A, UDI/DI 20193489111726 (case), 10193489111729 (unit), Lot Numbers: 2022022180; z) REF EBSI1088B, UDI/DI 00653160352689 (case), 10653160352686 (unit), Lot Numbers: 2022061380, 2022082280; aa) REF EBSI1245B, UDI/DI 20193489110828 (case), 10193489110821 (unit), Lot Numbers: 2022031480, 2022082280; bb) REF DYNDC2925B, UDI/DI 00653160349832 (case), 10653160349839 (unit), Lot Numbers: 2022012450, 2022021050, 2022022180; cc) REF EBSI1472A, UDI/DI 20193489112594 (case), 10193489112597 (unit), Lot Numbers: 2021122950, 2022021480; dd) REF EBSI1110C, UDI/DI 00653160352269 (case), 10653160352266 (unit), Lot Numbers: 2022052380; ee) REF EBSI1547, UDI/DI 00653160352276 (case), 10653160352273 (unit), Lot Numbers: 2022050980; ff) REF EBSI1453, UDI/DI 20193489110194 (case), 10193489110197 (unit), Lot Numbers: 2022022180, 2022032880; gg) REF EBSI1476, UDI/DI 20193489110156 (case), 10193489110159 (unit), Lot Numbers: 2022012480, 2022082280; hh) REF EBSI1413A, UDI/DI 20193489112198 (case), 10193489112191 (unit), Lot Numbers: 2022031480; ii) REF EBSI1513, UDI/DI 20193489112617 (case), 10193489112610 (unit), Lot Numbers: 2021122950, 2022012480; jj) REF EBSI1163B, UDI/DI 20193489112112 (case), 10193489112115 (unit), Lot Numbers: 2022050980, 2022061380; kk) REF EBSI1415A, UDI/DI 20193489112235 (case), 10193489112238 (unit), Lot Numbers: 2022021650; ll) REF EBSI1161A, UDI/DI 20193489111801 (case), 10193489111804 (unit), Lot Numbers: 2022012480, 2022022880, 2022082280; mm) REF EBSI1524, UDI/DI 00653160349238 (case), 10653160349235 (unit), Lot Numbers: 2021122950, 2022082280; nn) REF EBSI1524, UDI/DI 00653160350784 (case), 10653160350781 (unit), Lot Numbers: 2021122950, 2022082280; oo) REF EBSI1555, UDI/DI 00653160354508 (case), 10653160354505 (unit), Lot Numbers: 2022082280; pp) REF DYNDC3135, UDI/DI 20193489111221 (case), 10193489111224 (unit), Lot Numbers: 2022032180, 2022040480, 2022061380, 2022062080, 2022082280; qq) REF DT22500A, UDI/DI 00653160349795 (case), 10653160349792 (unit), Lot Numbers: 2022020850, 2022050950, 2022061380; rr) REF DYNDC3087, UDI/DI 20193489110477 (case), 10193489110470 (unit), Lot Numbers: 2022013180, 2022020180, 2022020280; ss) REF EBSI1471A, UDI/DI 20193489112600 (case), 10193489112603 (unit), Lot Numbers: 2021121750, 2022020780; tt) REF EBSI1512, UDI/DI 20193489112624 (case), 10193489112627 (unit), Lot Numbers: 2022013180; uu) REF EBSI1546, UDI/DI 00653160352283 (case), 10653160352280 (unit), Lot Numbers: 2022050280; vv) REF EBSI1486, UDI/DI 20193489111184 (case), 10193489111187 (unit), Lot Numbers: 2022041880, 022082280; ww) REF EBSI1523, UDI/DI 00653160349191 (case), 10653160349198 (unit), Lot Numbers: 2021122950, 2022040480; xx) REF DYNDC2703A, UDI/DI 00653160348675 (case), 10653160348672 (unit), Lot Numbers: 2022012480, 2022061380; yy) REF EBSI1434A, UDI/DI 00653160348620 (case), 10653160348627 (unit), Lot Numbers: 2021122150, 2022012480, 2022061380; zz) REF EBSI1525, UDI/DI 00653160349214 (case), 10653160349211 (unit), Lot Numbers: 2021122950; aaa) REF EBSI1525, UDI/DI 00653160350791 (case), 10653160350798 (unit), Lot Numbers: 2021122950; bbb) REF EBSI1208A, UDI/DI 00653160349047 (case), 10653160349044 (unit), Lot Numbers: 2022021480, 2022082280; ccc) REF EBSI1556, UDI/DI 00653160354492 (case), 10653160354499 (unit), Lot Numbers: 2022082280

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 29 of 49

Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;

Z-1118-2024
Recall number
Z-1118-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
12000 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF SUT12825, UDI/DI 00653160356199 (case), 10653160356196 (unit), Lot Numbers: 23CBX773, 23EBB756, 23HBC776; b) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers: 22EBC554, 22EBK107, 22EBR701, 22GBW369, 22JBI962, 22KBA966, 23DBD424, 23FBK832, 23GBR277, 23HBX352,; c) REF DYNDL1484B, UDI/DI 20193489198741 (case), 10193489198744 (unit), Lot Numbers: 22HLB333, 22ILA328, 22KLA754, 22LLA450, 23ALA763, 23BLA321, 23BLA885, 23CLA874, 23FLA147, 23FLB061, 23HLA382

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 30 of 49

Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594

Z-1119-2024
Recall number
Z-1119-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
991,744 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYND40589, UDI/DI 40080196032823 (case), 10080196032822, (unit), Lot Numbers: 2022032590, 2022033190, 2022040190, 2022040790, 2022041490, 2022041890, 2022050690, 2022052090, 2022060990, 2022062990, 2022071390, 2022063090, 2022071590, 2022071290, 2022071890, 2022080290, 2022080190, 2022080390, 2022080590, 2022090890, 2022091290, 2022091490, 2022092990, 2022101790, 2022111490, 2022113090, 2022122390, 2023011190, 2023011390, 2023020690, 2023020790, 2023020990, 2023021090, 2023030990, 2023031090, 2023031490, 2023031690, 2023031790, 2023032190, 2023033190, 2023040490, 2023040390, 2023042590, 2023041090, 2023042790, 2023042690, 2023042890, 2023050190, 2023051990, 2023052590, 2023052490, 2023052690, 2023052790, 2023053090, 2023053190, 2023060990, 2023061390, 2023061490, 2023061690, 2023061790, 2023061590, 2023062890, 2023080190, 2023090490, 2023090590, 2023090890, 2023090690, 2023090790, 2023100490, 2023101190; b) REF DYNDA3004, UDI/DI 00653160355543 (case), 10653160355540, (unit), Lot Numbers: 2022122090; c) REF DYND40650, UDI/DI 40080196855293 (case), 10080196855292, (unit), Lot Numbers: 2022042290, 2022061790, 2022090290, 2022101290, 2022112990, 2023022190, 2023040690, 2023052590, 2023062690, 2023072790; d) REF DYND40594, UDI/DI 40080196032854 (case), 10080196032853, (unit), Lot Numbers: 2022032890, 2022071490, 2022090290, 2022092790, 2022111190, 2023021090, 2023080290, 2023090190

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 31 of 49

Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002

Z-1120-2024
Recall number
Z-1120-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
72,624 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

REF DYND06002, UDI/DI 40080196816645 (case), 10080196816644 (unit), Lot Numbers: 2022041290, 2022051090, 2022062090, 2022081190, 2022081790, 2022101990, 2022102090, 2022111490, 2023050390, 2023050890, 2023042890, 2023050490, 2023063090, 2023062990, 2023070390, 2023072890, 2023082590

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 32 of 49

Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024

Z-1121-2024
Recall number
Z-1121-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
844 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF EDUC05053B, UDI/DI 40195327152759 (case), 10195327152758 (unit), Lot Numbers: 22HDA208; b) REF EDUC05054B, UDI/DI 40195327152766 (case), 10195327152765 (unit), Lot Numbers: 22FDA648, 22GDA631; c) REF EDUC05050B, UDI/DI 40195327166749 (case), 10195327166748 (unit), Lot Numbers: 22HLA620, 22HLB059, 22ILA209, 22ILA210, 22KLA131, 22LLA961, 23GLA207, 23GLA933, 23GLB218, 23HLB203; d) REF EDUC1024, UDI/DI 40195327493166 (case), 10195327493165 (unit), Lot Numbers: 23CDB444, 23EDB632, 23GDA553, 23GDB595, 23HDA559, 23IDA904, 23JDA398

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 33 of 49

Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;

Z-1122-2024
Recall number
Z-1122-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
2903 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF CDS980273D, UDI/DI 40884389851808 (case), 10884389851807 (unit), Lot Numbers: 22DBJ834; b) REF DYNJ907794, UDI/DI 40193489884952 (case), 10193489884951 (unit), Lot Numbers: 22BBB085, 22CBW699, 22FBH326, 22KBJ007, 22KBW578, 23ABL612, 23CBT573, 23HBD177; c) REF DYNDL1864A, UDI/DI 40889942721420 (case), 10889942721429 (unit), Lot Numbers: 22FBN858, 22IBN393, 23ABJ223, 23EBK530, 23HBS351; d) REF DYNJ908877, UDI/DI 40195327201747 (case), 10195327201746 (unit), Lot Numbers: 22HBT779, 22KBH144, 22LBM695, 23ABD156; e) REF DYNJ83093, UDI/DI 40195327230870 (case), 10195327230869 (unit), Lot Numbers: 22JME508, 23CMH924, 23DMH299, 23EMC295, 23FMB041

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 34 of 49

Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V

Z-1123-2024
Recall number
Z-1123-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
533 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF CDS984900M, UDI/DI 40195327265671 (case), 10195327265670 (unit), Lot Numbers: 22KBW682; b) REF CDS983913S, UDI/DI 40195327057139 (case), 10195327057138 (unit), Lot Numbers: 22EBH289, 22EBI056, 22GBC582, 22GBH056, 22JBN751, 22NBC011; c) REF CDS983913T, UDI/DI 40195327238378 (case), 10195327238377 (unit), Lot Numbers: 22KBK694, 23BBA876, 23BBA877, 23BBN921; d) REF CDS983913U, UDI/DI 40195327403158 (case), 10195327403157 (unit), Lot Numbers: 23EBE521, 23EBK643; e) REF CDS983913V, UDI/DI 40195327417820 (case), 10195327417819 (unit), Lot Numbers: 23GBL963, 23GBO775, 23HBI553, 23IBR322

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 35 of 49

Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G

Z-1124-2024
Recall number
Z-1124-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
483 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

REF DYNJ904653G, UDI/DI 40195327277660 (case), 10195327277659 (unit), Lot Numbers: 22KBM559, 22KBM896, 23CBU919

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 36 of 49

Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G

Z-1125-2024
Recall number
Z-1125-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
279 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF CDS983911J, UDI/DI 40193489402668 (case), 10193489402667 (unit), Lot Numbers: 22EBU168, 22KBI115, 22LBL299, 22NBD200, 22NBF154, 23ABE617, 23ABU424, 23CBT642, 23IBM022, 23JBC180; b) REF DYNJ67214F, UDI/DI 40195327277803 (case), 10195327277802 (unit), Lot Numbers: 22LBT250, 23BBM551, 23CBS078; c) REF DYNJ67214G, UDI/DI 40195327411306 (case), 10195327411305 (unit), Lot Numbers: 23GBI555

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 37 of 49

Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT, REF DYKM2222; h) EYE PLASTIC PACK, REF DYNJ47859C; i) K PACK, REF LYN030KAGVD; j) OCULOPLASTY PACK, REF DYNJ64572A; k) OL OCULAR, REF DYNJ906183J; l) OL OCULAR, REF DYNJ906183K; m) P M CATARACT, REF DYNJ44917G; n) P M CATARACT, REF DYNJ44917I; o) P PACK, REF LYN030POGVD; p) R VITRECTOMY, REF EYP087W; q) VITRECTOMY PACK, REF DYNJ68884B

Z-1126-2024
Recall number
Z-1126-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
5724 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF VAL011CTASD, UDI/DI 40195327152032 (case), 10195327152031 (unit), Lot Numbers: 22LBB812, 22LBH455; b) REF DYNJ68875F, UDI/DI 40195327382125 (case), 10195327382124 (unit), Lot Numbers: 23FBQ273, 23GBS122, 23GBS486, 23HBP752; c) REF DYNJ54869F, UDI/DI 40195327407286 (case), 10195327407285 (unit), Lot Numbers: 23FBQ273, 23GBS122, 23GBS486, 23HBP752; d) REF DYNJ44917L, UDI/DI 40195327472604 (case), 10195327472603 (unit), Lot Numbers: 23HBS811; e) REF CDS983585G, UDI/DI 40193489460781 (case), 10193489460780 (unit), Lot Numbers: 22DBI589, 22HBA111, 22JBQ351, 23EBG770; f) REF CDS983916G, UDI/DI 40193489803861 (case), 10193489803860 (unit), Lot Numbers: 22CBV428, 22GBP859, 22HBP383, 23EBP259, 23GBG620, 23IBS207, 23JBW354; g) REF DYKM2222, UDI/DI 40195327337255 (case), 10195327337254 (unit), Lot Numbers: 23DBI071; h) REF DYNJ47859C, UDI/DI 40193489916066 (case), 10193489916065 (unit), Lot Numbers: 23EBA347; i) REF LYN030KAGVD, UDI/DI 40193489956574 (case), 10193489956573 (unit), Lot Numbers: 22ABH632, 22ABW357, 22CBL660, 22IBS624; j) REF DYNJ64572A, UDI/DI 40195327112555 (case), 10195327112554 (unit), Lot Numbers: 22GBL794; k) REF DYNJ906183J, UDI/DI 40195327279449 (case), 10195327279448 (unit), Lot Numbers: 22LMC016, 22LMH698, 23AME088, 23AMF669, 23BMH365, 23CMB182, 23EMA555; l) REF DYNJ906183K, UDI/DI 40195327385522 (case), 10195327385521 (unit), Lot Numbers: 23FMC104, 23FME336, 23GMD288, 23HMH680; m) REF DYNJ44917G, UDI/DI 40195327031481 (case), 10195327031480 (unit), Lot Numbers: 22BBV644; n) REF DYNJ44917I, UDI/DI 40195327156375 (case), 10195327156374 (unit), Lot Numbers: 22FBN595, 22IBK002; o) REF LYN030POGVD, UDI/DI 22ABM649, 22ABW358, 22BBK347, 22CBT855, 22EBR210, 22HBR247, 22KBH816, 22LBA956, 22OBF733, 23ABB019, 23BBQ119; p) REF EYP087W, UDI/DI 50653160050221 (case), 00653160050226 (unit), Lot Numbers: 40195327037254 (case), 10195327037253 (unit), Lot Numbers: 22CBF187, 22EBE045, 22FBO783, 22GBZ358, 22IBF001, 22JBC220, 22KBN864, 22OBE478, 23ABG110, 23BBR173, 23DBH202; q) REF DYNJ68884B, UDI/DI 40195327059010 (case), 10195327059019 (unit), Lot Numbers: 22GBG399

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 38 of 49

Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F; g) EXTREMITY IV, REF CMPJ06040D; h) EXTREMITY IV, REF CMPJ06040F; i) EXTREMITY PROCEDURE, REF CDS981656I; j) FACIAL PLASTY PACK, REF DYNJ55335D; k) FOOT PROCEDURE, REF CDS981659I; l) FOOT PROCEDURE, REF CDS981659J; m) HAND, REF DYNJ902002J; n) HAND PACK, REF DYNJ35744A; o) HAND PACK, REF DYNJ68873C; p) HAND PACK, REF DYNJ46211K; q) KNEE ARTHROSCOPY CDS, REF CDS941004C; r) KNEE PACK, REF DYNJ68512; s) LACERATION TRAY, REF SUT21580; t) LOWER EXTREMITY, REF DYNJ907121F; u) LOWER EXTREMITY, REF DYNJ46222M; v) LOWER EXTREMITY PACK, REF DYNJ67216C; w) LOWER EXTREMITY PACK, REF DYNJ67216D; x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892; y) PODIATRY PACK, REF DYNJ68347A; z) PODIATRY PACK, REF DYNJ68347B; aa) PODIATRY PACK-LF, REF DYNJ34648D; bb) POSTERIOR PACK, REF DYNJ64576A; cc) SHOULDER, REF DYNJ903011J; dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G; ee) SHOULDER KIT, REF DYNJ907705D; ff) SMALL HAND CDS, REF DYNJ902002G; gg) SMALL HAND CDS, REF DYNJ902002I; hh) SMALL HAND PACK, REF CMPJ06038F; ii) SMALL HAND PACK, REF CMPJ06038G; jj) TOTAL KNEE, REF DYNJ909159; kk) TOTAL KNEE CDS, REF CDS982823P; ll) TOTAL KNEE CDS, REF CDS982823Q; mm) TRIGGER FINGER KIT, REF DYNJ68406; nn) UPPER EXTREMITY, REF DYNJ907130C

Z-1127-2024
Recall number
Z-1127-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
14280 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYNJ64814A, UDI/DI 40195327112807 (case), 10195327112806 (unit), Lot Numbers: 22FBD779, 22JBN895; b) REF DYNDH1629, UDI/DI 40193489917360 (case), 10193489917369 (unit), Lot Numbers: 22ABP606; c) REF DYNJ48587A, UDI/DI 40889942313106 (case), 10889942313105 (unit), Lot Numbers: 22JBQ342, 23ABL345, 23CBJ954, 23DBK384, 23FBQ607; d) REF CDS983313I, UDI/DI 40193489424540 (case), 10193489424539 (unit), Lot Numbers: 22DDA444, 22EDB075, 23ADB093, 23CDC442, 23DDA819, 23EDC367; e) REF DYNJ902004D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers: 22FBR327, 22JBQ099; f) REF DYNJ902004F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers: 23BBF818, 23BBN981, 23HBL676, 23IBA162, 23IBJ945; g) REF CMPJ06040D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers: 22EBU873, 22IBA206; h) REF CMPJ06040F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers: 23ABN951, 23ABU853, 23GBV583, 23GBW733, 23HBK120; i) REF CDS981656I, UDI/DI 40193489433884 (case), 10193489433883 (unit), Lot Numbers: 22BDB050, 22EDB527, 22FDB578, 23BDA698, 23BDB738, 23EDA039; j) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers: 23JBB690; k) REF CDS981659I, UDI/DI 40193489433907 (case), 10193489433906 (unit), Lot Numbers: 23BDB207, 23DDA594, 23EDA040, 23FDB570; l) REF CDS981659J, UDI/DI 40195327398508 (case), 10195327398507 (unit), Lot Numbers: 23JBM035; m) REF DYNJ902002J, UDI/DI 40195327516070 (case), 10195327516079 (unit), Lot Numbers: 22DBB588, 23DBA171, 23EBL341, 23FBA124, 23FBU113, 23FBV329, 23GBN600, 23GBQ956, 23JBA529; n) REF DYNJ35744A, UDI/DI 40889942600596 (case), 10889942600595 (unit), Lot Numbers: 22DBB588; o) REF DYNJ68873C, UDI/DI 40195327375691 (case), 10195327375690 (unit), Lot Numbers: 23FBA124, 23FBU113, 23FBV329, 23GBQ956; p) REF DYNJ46211K, UDI/DI 40195327407484 (case), 10195327407483 (unit), Lot Numbers: 23DBA171, 23EBL341, 23GBN600, 23JBA529; q) REF CDS941004C, UDI/DI 40888277507471 (case), 10888277507470 (unit), Lot Numbers: 22ALA255, 22IMA552; r) REF DYNJ68512, UDI/DI 40193489828956 (case), 10193489828955 (unit), Lot Numbers: 21KBI896, 22BBV355, 22EBN387, 22EBP166, 22FBA911, 22FBL484, 22IBO503, 22JBW455, 22KBM697, 22LBN605, 22LBQ786, 23BBB214, 23BBS153, 23EBO560, 23GBN713, 23HBH102, 23JBL709; s) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers: 23EBL458; t) REF DYNJ907121F, UDI/DI 40195327222087 (case), 10195327222086 (unit), Lot Numbers: 22LBR588; u) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23HBP767, 23IBW177; v) REF DYNJ67216C, UDI/DI 40195327280674 (case), 10195327280673 (unit), Lot Numbers: 22LLA847, 23CLA146; w) REF DYNJ67216D, UDI/DI 40195327405183 (case), 10195327405182 (unit), Lot Numbers: 23ELA164, 23FLA372; x) REF DYNJ906892, UDI/DI 40193489281461 (case), 10193489281460 (unit), Lot Numbers: 22GBI467, 22GBM602, 22OBH187, 22OBJ425, 22OBK650; y) REF DYNJ68347A, UDI/DI 40193489934107 (case), 10193489934106 (unit), Lot Numbers: 22ABK059, 22BBU107, 22CBS838; z) REF DYNJ68347B, UDI/DI 40195327141197 (case), 10195327141196 (unit), Lot Numbers: 22FBG492, 22FBU866; aa) REF DYNJ34648D, UDI/DI 40193489916165 (case), 10193489916164 (unit), Lot Numbers: 22HBH536; bb) REF DYNJ64576A, UDI/DI 40195327111954 (case), 10195327111953 (unit), Lot Numbers: 22GBL600; cc) REF DYNJ903011J, UDI/DI 40195327437573 (case), 10195327437572 (unit), Lot Numbers: 23IBF175, 23JBS067; dd) REF CDS981658G, UDI/DI 40193489876827 (case), 10193489876826 (unit), Lot Numbers: 22CDC277, 23DDB287; ee) REF DYNJ907705D, UDI/DI 40195327375783 (case), 10195327375782 (unit), Lot Numbers: 23EBU785, 23JBF717, 23KBA709; ff) REF DYNJ902002G, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers: 22HBA403, 22HBS428, 22IBE726; gg) REF DYNJ902002I, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers: 22LBS865, 23ABO144, 23BBR667, 23DBS266, 23EBT050, 23FBE713, 23HBQ460; hh) REF CMPJ06038F, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers: 22EBI104, 22HBO484; ii) REF CMPJ06038G, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers: 22KBG879, 22KBU962, 23BBD874, 23DBA902, 23DBK147, 23EBQ126, 23GBQ295; jj) REF DYNJ909159, UDI/DI 40195327280896 (case), 10195327280895 (unit), Lot Numbers: 23EBS908; kk) REF CDS982823P, UDI/DI 40193489402760 (case), 10193489402759 (unit), Lot Numbers: 22OBI091; ll) REF CDS982823Q, UDI/DI 40195327238340 (case), 10195327238339 (unit), Lot Numbers: 23ABT038, 23BBK666, 23EBJ570, 23FBL610, 23HBE191, 23JBD296, 23JBR325; mm) REF DYNJ68406, UDI/DI 40193489440363 (case), 10193489440362 (unit), Lot Numbers: 22OBK988; nn) REF DYNJ907130C, UDI/DI 40193489821636 (case), 10193489821635 (unit), Lot Numbers: 23ABD199

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 39 of 49

Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474; f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476; g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478; h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442

Z-1128-2024
Recall number
Z-1128-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
1,012,700 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DYND41470, UDI/DI 40080196033608(case), 10080196033607(unit), Lot Numbers: 2022042690, 2022070690, 2022090790, 2022102590, 2023051790; b) REF DYND41471, UDI/DI 40080196033622(case), 10080196033621(unit), Lot Numbers: 2022070190, 2022072890, 2022101090, 2022121390, 2022121990, 2023022890, 2023051890; c) REF DYND40442, UDI/DI 40080196032618(case), 10080196032617(unit), Lot Numbers: 2022040590, 2022051890, 2022072290, 2022090690, 2022100790, 2022093090, 2022101190, 2022122890, 2023051290, 2023060590, 2023080290, 2023092690; d) REF DYND41472, UDI/DI 40080196996538(case), 10080196996537(unit), Lot Numbers: 2022042590, 2022062390, 2022070590, 2022072590, 2022080890, 2022082590, 2023010690, 2023022790, 2023030890, 2023041090, 2023041990, 2023070590; e) REF DYND41474, UDI/DI 40080196033653(case), 10080196033652(unit), Lot Numbers: 2022082390, 2022101090, 2022121290, 2022122090, 2023030390, 2023070590, 2023092590; f) REF DYND41476, UDI/DI 40080196033660(case), 10080196033669(unit), Lot Numbers: 2022062290, 2022072890, 2022102490, 2022122090, 2023030190, 2023051990; g) REF DYND41478, UDI/DI 40080196033677(case), 10080196033676(unit), Lot Numbers: 2022042890, 2022070690, 2022082390, 2022100690, 2022121290, 2023010490, 2023041490, 2023080890, 2023092590; h) REF DYND41442, UDI/DI 40080196033578(case), 10080196033577(unit), Lot Numbers: 2022031590, 2022032290, 2022042790, 2022060290, 2022053190, 2022052790, 2022060690, 2022072690, 2022072790, 2022082490, 2022102490, 2023012490, 2023030390, 2023032390, 2023032490, 2023041790, 2023060190, 2023060290, 2023070590

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 40 of 49

Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

Z-1129-2024
Recall number
Z-1129-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
220 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

UDI/DI 00653160348477 (case), 10653160348474 (unit), Lot Numbers: 2022031480, 2022041180

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 41 of 49

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

Z-1130-2024
Recall number
Z-1130-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
10391 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF MNS10750A, UDI/DI 00653160348286 (case), 10653160348283 (unit), Lot Numbers: 2022032150, 2022053150, 2022061750, 2022073050; b) REF DT21235A, UDI/DI 00653160348453 (case), 10653160348450 (unit), Lot Numbers: 2022012701; c) REF DYNDC3166A, UDI/DI 00653160350111 (case), 10653160350118 (unit), Lot Numbers: 2022021150, 2022031450, 2022031850

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 42 of 49

Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010

Z-1131-2024
Recall number
Z-1131-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
60 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

REF ET1010, UDI/DI 10653160234913 (case), 00653160234916 (unit), Lot Numbers: 2022042290

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 43 of 49

Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY, REF SUT19510; g) LACERATION TRAY, REF SUT8565; h) LACERATION TRAY, REF SUT8565; i) LINE REPAIR KIT, REF MNS12045A; j) MMC DAILY DRIVELINE MGMT KIT, REF DM850A; k) NEWBORN THORACOTOMY TRAY, REF MNS3470; l) NICU STERILE CENTRAL LINE CHANGE KIT, REF DT18520A; m) OMMAYA KITS - LATEX FREE, REF HT2375; n) PEDIATRIC ULTRASOUND KIT, REF MNS12995A; o) PORT ACCESS INFUSION KIT - 1IN NEEDLE, REF DYNDC2817C; p) WOUND CLOSURE AND IRRIGATION TRAY, REF SUT14785;

Z-1132-2024
Recall number
Z-1132-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
14234 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) MNS13600, 00653160349887 (case), 10653160349884 (unit), Lot Numbers: 2022022350, 2022041880; b) DM640A, 00653160357271 (case), 10653160357278 (unit), Lot Numbers: 2022122090, 2022122890, 2023073190; c) CIT6180, 00653160290691 (case), 10653160290698 (unit), Lot Numbers: 2023080290; d) ID1690, 10653160235903 (case), 00653160235906 (unit), Lot Numbers: 2022071390, 2022120790, 2023062690; e) SUT19510, 00653160352436 (case), 10653160352433 (unit), Lot Numbers: 2022041880, 2022071180, 2022071280; f) SUT19510, 00653160356199 (case), 10653160356196 (unit), Lot Numbers: 2022120290, 2023033090, 2023052290, 2023080190; g) SUT8565, 50653160016845 (case), 00653160016840 (unit), Lot Numbers: 2022042580; h) SUT8565, 00653160356182 (case), 10653160356189 (unit), Lot Numbers: 2023020690, 2023030390, 2023050390, 2023091890; i) MNS12045A, 00653160350340 (case), 10653160350347 (unit), Lot Numbers: 2022032850, 2022041180, 2022041280; j) DM850A, 00653160354096 (case), 10653160354093 (unit), Lot Numbers: 2022072890, 2022090690, 2022112290, 2023030390, 2023070390; k) MNS3470, 10653160106029 (case), 00653160106022 (unit), Lot Numbers: 2022031790, 2022091390, 2022110890, 2023011690, 2023052290, 2023080790; l) DT18520A, 00653160351491 (case), 10653160351498 (unit), Lot Numbers: 2022082280, 2022082980; m) HT2375, 50653160050221 (case), 00653160050226 (unit), Lot Numbers: 2023061290, 023092190; n) MNS12995A, 00653160349818 (case), 10653160349815 (unit), Lot Numbers: 2022031750, 2022031850, 2022082980; o) DYNDC2817C, 00653160348361 (case), 10653160348368 (unit), Lot Numbers: 2022012480, 2022050980; p) SUT14785, 10653160193081 (case), 00653160193084 (unit), Lot Numbers: 2022060290, 2022110490, 2023040390, 2023052490, 2023061390, 2023091490

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 44 of 49

Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170

Z-1133-2024
Recall number
Z-1133-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
528 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

REF TC7170, UDI/DI 50653160043629 (case), 00653160043624 (unit), Lot Numbers: 2022042790, 2022121290, 2023031790, 2023042490; 2023092190

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 45 of 49

Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A

Z-1134-2024
Recall number
Z-1134-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
11812 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF IVS1860B, UDI/DI 00653160351354 (case), 10653160351351 (unit), Lot Numbers: 2022041880, 2022082280; b) REF CVI2025, UDI/DI 50653160060459 (case), 00653160060454 (unit), Lot Numbers: 2022053190; c) REF CVI4570, UDI/DI 00653160323382 (case), 10653160323389 (unit), Lot Numbers: 2022042690, 2022072590, 2022103190, 2023041290, 2023051090; d) REF IV8695A, UDI/DI 00653160348569 (case), 10653160348566 (unit), Lot Numbers: 2021121750, 2022030780

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 46 of 49

Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A

Z-1135-2024
Recall number
Z-1135-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
576 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF ST11670A, UDI/DI 10653160166382 (case), 00653160166385 (unit), Lot Numbers: 2022042590, 2022111690, 2023020690, 2023040690, 2023063090, 2023091390,

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 47 of 49

Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f) DRESSING CHANGE TRAY WITHOUT DRESSING, REF DT21465B; g) DRIVELINE MANAGEMENT SYSTEM, REF DT18905; h) DRIVELINE MANAGEMENT SYSTEM-DAILY, REF DM610; i) DRIVELINE MGMT TRAY W/O ANCHOR, REF DT18210; j) DRIVELINE MGMT. KIT WITH SILVER ALGINATE, REF DT18695A; k) LVAD DAILY PATIENT CHANGE KIT, REF DM630; l) LVAD DAILY PATIENT CHANGE KIT, REF DM630; m) LVAD DRIVELINE MGMT KIT, SENSITIVE SKIN, REF DT19005A; n) LVAD MAINTENANCE KIT - LESS THAN 6 MOS., REF DM1060; o) LVAD SENSITIVE KIT, REF DM525A; p) MMC DAILY DRIVELINE MGMT KIT, REF DM850; q) PATIENT DRESSING CHANGE KIT SW, REF DT17355; r) PEDIATRIC PORT ACCESS BUNDLE, REF DT19835B; s) PORT ACCESS KIT, REF DT22575A; t) PORT ACCESS TRAY, REF DT20845B; u) PORT DRESSING CHANGE TRAY, REF DT20885B; v) PORT DRESSING CHANGE KIT, REF DT21585B; w) PORT DRESSING CHANGE KIT, REF DYNDC2815A; x) PORT KIT, REF DT22270A; y) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; z) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; aa) VAD DRESSING CHANGE TRAY, REF DM875; bb) VAD DRESSING CHANGE TRAY, REF DM875; cc) VAD DRIVELINE MANAGEMENT KIT HW, REF DM1105

Z-1136-2024
Recall number
Z-1136-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
113249 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

a) REF DM405A, UDI/DI 00653160322217 (case), 10653160322214 (unit), Lot Numbers: 2022042580, 2022070580, 2022071180, 2022071880, 2022072580, 2022080180, 2023040380, 2023050180, 2023073180, 2023102380; b) REF DM640, UDI/DI 00653160289602 (case), 10653160289609 (unit), Lot Numbers: 2022041390; c) REF DM600, UDI/DI 00653160352610 (case), 10653160352617 (unit), Lot Numbers: 2022041880, 2023081480; d) REF DM870A, UDI/DI 00653160348217 (case), 10653160348214 (unit), Lot Numbers: 2022020780; e) REF DM870A, UDI/DI 00653160352382 (case), 10653160352389 (unit), Lot Numbers: 2022041880; f) REF DT21465B, UDI/DI 00653160350005 (case), 10653160350002 (unit), Lot Numbers: 2022012550, 2022032880, 2022032980, 2022082280; g) REF DT18905, UDI/DI 00653160275063 (case), 10653160275060 (unit), Lot Numbers: 2022040590, 2022041390, 2022081990, 2023011290, 2023012490, 2023051190, 2023061290, 2023081590, 2023101790; h) REF DM610, UDI/DI 00653160294002 (case), 10653160294009 (unit), Lot Numbers: 2022050980, 2022072580, 2022072680, 2022080180, 2022080880, 2022081580, 2023050880, 2023061280, 2023072480, 2023081480, 2023082880; i) REF DT18210, UDI/DI 00653160352658 (case), 10653160352655 (unit), Lot Numbers: 2022042290; j) REF DT18695A, UDI/DI 00653160315127 (case), 10653160315124 (unit), Lot Numbers: 2022042790, 2022103190, 2023012790, 2023032490, 2023032890, 2023052690, 2023072890, 2023092190; k) REF DM630, UDI/DI 00653160288568 (case), 10653160288565 (unit), Lot Numbers: 2022033190; l) REF DM630, UDI/DI 00653160352450 (case), 10653160352457 (unit), Lot Numbers: 2022050590, 2022111790, 2023011990, 2023031590, 2023042490, 2023062690, 2023081490; m) REF DT19005A, UDI/DI 00653160349801 (case), 10653160349808 (unit), Lot Numbers: 2022050980; n) REF DM1060, UDI/DI 00653160352443 (case), 10653160352440 (unit), Lot Numbers: 2022050280, 2023070380, 2023082180, 2023082880, 2023101680; o) REF DM525A, UDI/DI 00653160352511 (case), 10653160352518 (unit), Lot Numbers: 2022042580, 2022080180, 2022112880, 2022112980; p) REF DM850, UDI/DI 00653160307047 (case), 10653160307044 (unit), Lot Numbers: 2022040490; q) REF DT17355, UDI/DI 00653160265170 (case), 10653160265177 (unit), Lot Numbers: 2022082290, 2022090190, 2022112990, 2023012490, 2023042090, 2023070690, 2023073190, 2023081190; r) REF DT19835B, UDI/DI 00653160350128 (case), 10653160350125 (unit), Lot Numbers: 2022021150, 2022022250; s) REF DT22575A, UDI/DI 00653160349825 (case), 10653160349822 (unit), Lot Numbers: 2022011350, 2022052380, 2022052480, 2022052580; t) REF DT20845B, UDI/DI 00653160348842 (case), 10653160348849 (unit), Lot Numbers: 2022010750, 2022031450; u) REF DT20885B, UDI/DI 00653160348422 (case), 10653160348429 (unit), Lot Numbers: 2022052380; v) REF DT21585B, UDI/DI 00653160351439 (case), 10653160351436 (unit), Lot Numbers: 2022042050, 2022051680; w) REF DYNDC2815A, UDI/DI 00653160348316 (case), 10653160348313 (unit), Lot Numbers: 2022031450, 2022041180, 2022041280, 2022041380, 2022062080; x) REF DT22270A, UDI/DI 00653160348255 (case), 10653160348252 (unit), Lot Numbers: 2022011350, 2022022880; y) REF DM330A, UDI/DI 00653160324051 (case), 10653160324058 (unit), Lot Numbers: 2023081090, 2022042580, 2022103180, 2023020680, 2023042480; z) REF DM330A, UDI/DI 00653160366655 (case), 10653160366652 (unit), Lot Numbers: 2023101190; aa) REF DM875, UDI/DI 00653160309614 (case), 10653160309611 (unit), Lot Numbers: 2022040490; bb) REF DM875, UDI/DI 00653160352504 (case), 10653160352501 (unit), Lot Numbers: 2022041290, 2022042590, 2022051990, 2022081990, 2022120990, 2023042790, 2023053090, 2023071490, 2023101290; cc) REF DM1105, UDI/DI 00653160343519 (case), 10653160343516 (unit), Lot Numbers: 2022032490

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 48 of 49

Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360

Z-1137-2024
Recall number
Z-1137-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
120 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

REF MNS4360, UDI/DI 10653160141716 (case), 00653160141719 (unit), Lot Numbers: 2022091690, 2022112290, 2022120990

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

device · product 49 of 49

Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271

Z-1138-2024
Recall number
Z-1138-2024
Initiated
November 15, 2023
Classification
Class I
Status
Ongoing
Quantity
1260 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Code information

REF DYNDA2271, UDI/DI 00653160318920 (case), 10653160318927 (unit), Lot Numbers: 2022042590, 2022070190, 2022082290, 2022111490, 2023022190, 2023063090, 2023090790

Distribution pattern

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama