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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92399

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

Open FDA event record

Event summary

Timeline bucket
May 15, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

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

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

How coverage and grouping work

Complete imported group

Every recalled product in this event

50 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 50

Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900

Z-2290-2023
Recall number
Z-2290-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
1,231,480 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

a. Model Number DYNJE5900; UDI-DI Each: 10884389114124, Case: 40884389114125; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920100011, 06920100011, 06920110011, 06920120011, 06920120011, 06921010011, 06921010011, 06921010022, 06921020011, 06921020021, 06921030021, 06921030031, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921050011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100012, 06921110011, 0692112H022, 0692112H022, 0692112H022, 0692201H011, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692205H011, 0692205H011; b. Model Number DYNJE5910; UDI-DI Each: 10884389114094, Case: 40884389114095; Lot Numbers: 06920120011, 06920120011, 06921010011, 06921030011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921110011, 06921120011, 0692112H022, 0692112H022, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692208H014; c. Model Number DYNJE5920; UDI-DI Each: 10884389114100, Case: 40884389114101; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920040022, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920090011, 06920100011, 06920100011, 06920110011, 06920120011, 06920120011, 06920120012, 06921010011, 06921020021, 06921030012, 06921030021, 06921030021, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921100011, 06921100012, 06921100013, 06921110011, 0692112H022, 0692112H022, 0692112H022, 0692202H011, 0692202H024, 0692203H011, 0692204H011, 0692204H011, 0692205H011, 0692205H012, 0692205H013, 0692205H013, 0692206H011; d. Model Number DYNJE5930; UDI-DI Each: 10884389114117, Case: 40884389114118; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920040022, 06920050011, 06920050011, 06920050011, 06920050012, 06920070011, 06920080012, 06920100011, 06920110011, 06920110011, 06920110011, 06920120011, 06920120011, 06921010011, 06921010011, 06921010011, 06921020021, 06921030021, 06921040011, 06921040011, 06921040011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100012, 06921120011, 0692112H022, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692203H011, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692205H011, 0692205H011, 0692206H011; e. Model Number DYNJE5940; UDI-DI Each: 10888277723641, Case: 20888277723648; Lot numbers: 06920050011, 06920060012, 06920060012, 06920070021, 06920100011, 06920110011, 06920110011, 06920110011, 06920110012, 06920120011, 06921050011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 0692201H011, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692203H011, 0692203H011, 0692204H011, 0692204H011; f. Model Number DYNJEX5900; UDI-DI Each: 10884389114124, Case: 40884389114125; Lot Numbers: 06920040022, 06920080012. **Lot format as follows: Example 069YYMM0001 where "069" is the last 3 digits of the vendor code for the probe cover kitting facility, "YYMM" is the year and month of manufacture of the probe cover kit, and "0001" is a sequential number for the month of production

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 2 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;

Z-2291-2023
Recall number
Z-2291-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
1,130 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ52283C; UPC Number: 019348965000. b. Model Number: DYNJ61476; UPC Number: 019348957199.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 3 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART995; d. ARTERIAL LINE INSERTION KIT, Model Number: ART775B; e. ARTERIAL LINE KIT W/O CATHETER, Model Number: ART890A; f. ARTERIAL LINE START KIT, Model Number: ART1160; g. ARTERIAL LINE START KIT W/O CATH, Model Number: P42453; h. ARTERIAL LINE TRAY W/O CATHETER, Model Number: ART1180; i. RADIAL ARTERIAL LINE KIT, Model Number: ART1070A

Z-2292-2023
Recall number
Z-2292-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
4,900 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ART900; UPC Number: 10653160342540. b. Model Number: DT22570; UPC Number: 10653160343851. c. Model Number: ART995; UPC Number: 10193489190502. d. Model Number: ART775B; UPC Number: 10653160353560. e. Model Number: ART890A; UPC Number: 10653160356677. f. Model Number: ART1160; UPC Number: 10653160355762. g. Model Number: P42453; UPC Number: 10653160323792. h. Model Number: ART1180; UPC Number: 10653160355472. i. Model Number: ART1070A. UPC Number: 10653160358329.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 4 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA1864; d. BLOCK KIT, Model Number: DYNJRA1893; e. DR LEWIS US TRAY, Model Number: DYNJRA1998; f. ECHOGENIC SINGLE SHOT TRAY, Model Number: DYNJRA1978, DYNJRA1978A, SAMPA0109; g. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739A; h. NERVE BLOCK INSERTION, Model Number: DYNJRA2027; i. NERVE BLOCK PREP TRAY, Model Number: DYNJRA1837; j. NERVE BLOCK TRAY, Model Number: DYNJRA1878, DYNJRA1900; k. NERVE PERIPHERAL PACK, Model Number: DYNJRA2055; l. PAIN BLOCK TRAY, Model Number: DYNJRA0827A; m. PAIN PREP TRAY W/PROBE COVER, Model Numbers: DYNJRA0881, DYNJRA1847, DYNJRA1975; n. PAIN PREP W/ PROBE COVER TRAY, Model Number: DYNJRA2028; o. PAIN PREP W/PROBE COVER TRAY, Model Number: PAIN1762; p. PAIN TRAY, Model Number: DYNJRA1603; q. PERIPHERAL NERVE CATHETER KT, Model Number: PAIN1560; r. PREOP NERVE BLOCK TRAY, Model Number: DYNJRA2040; s. PREP TRAY, Model Number: DYNJRA1498A; t. SINGLE SHOT BLOCK, Model Number: DYNJRA0961B; u. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA2077; v. TAP BLOCK, Model Number: DYNJRA1823; w. TRAY ULTRASOUND BLOCK 20G X 4, Model Number: DYNJRA9044; x. TRAY 18G CPNB 20G STYLETED, Model Number: DYNJRA9040; y. ULTRASOUND TRAY, Model Number: DYNJRA2022; z. US TPI KIT, Model Number: DYNJRA1945

Z-2293-2023
Recall number
Z-2293-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
29,277 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJRA1869; UPC Number: 019532701881. b. Model Number: DYNJRA0949C; UPC Number: 019348966504. c. Model Number: DYNJRA1864; UPC Number: 019348926312. d. Model Number: DYNJRA1893; UPC Number: 019532706282. e. Model Number: DYNJRA1998; UPC Number: 019532719429. f. Model Number: DYNJRA1978, UPC Number: 019348926312; Model Number: DYNJRA1978A, UPC Number: 019532732040; Model Number: SAMPA0109, UPC Number: 019532709698. g. Model Number: DYNJRA1739A; UPC Number: 019348992495. h. Model Number: DYNJRA2027; UPC Number: 019532722522. i. Model Number: DYNJRA1837. UPC Number: 019348997671. j. Model Number: DYNJRA1878, UPC Number: 019532704037; Model Number: DYNJRA1900, UPC Number: 019532708225. k. Model Number: DYNJRA2055, UPC Number: 019532725516. l. Model Number: DYNJRA0827A, UPC Number: 019348921446. m. Model Number: DYNJRA0881, UPC Number: 019348926312; Model Number: DYNJRA1847, UPC Number: 019348999366; Model Number: DYNJRA1975, UPC Number: 019532716324. n. Model Number: DYNJRA2028, UPC Number: 019348926312. o. Model Number: PAIN1762, UPC Number: 019348996209. p. Model Number: DYNJRA1603, UPC Number: 019348929900. q. Model Number: PAIN1560, UPC Number: 019348921538. r. Model Number: DYNJRA2040, UPC Number: 019532724369. s. Model Number: DYNJRA1498A, UPC Number: 019532712905. t. Model Number: DYNJRA0961B, UPC Number: 019532726771. u. Model Number: DYNJRA2077, UPC Number: 019532727891. v. Model Number: DYNJRA1823, UPC Number: 019348996188. w. Model Number: DYNJRA9044, UPC Number: 019348988811. x. Model Number: DYNJRA9040, UPC Number: 019348983051. y. Model Number: DYNJRA2022, UPC Number: 019532721816. z. Model Number: DYNJRA1945, UPC Number: 019532713305.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 5 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A

Z-2294-2023
Recall number
Z-2294-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
192 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

Model Number: DYNJ45158A, UPC Number: 088827750721, all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 6 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;

Z-2295-2023
Recall number
Z-2295-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
29,126 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ33638J, UPC Number: 019348956435. b. Model Number: DYNJRA1543, UPC Number: 019348921766. c. Model Number: DYNJRA1247, UPC Number: 019348950391. d. Model Number: DYNJ42367B, UPC Number: 019348921151. e. Model Number: DYNJRA1739, UPC Number: 019348926312. f. Model Number: DYNJ0134147D, UPC Number: 088994293734. g. Model Number: DYNJRA1220, UPC Number: 088827779503; Model Number: DYNJRA1571, UPC Number 019348926473. h. Model Number: DYNJRA1109A, UPC Number: 019348925132. i. Model Number: DYNJRA0656A, UPC Number: 088994222511; Model Number: DYNJRA1287A, UPC Number: 019348977309; Model Number: DYNJRA1604, UPC Number 019348929981. j. Model Number: DYNJRA0725, UPC Number: 019348926312. k. Model Number: DYNJ51107B, UPC Number: 019348981047. l. Model Number: DYNJRA1773, UPC Number: 019348986297. m. Model Number: PAIN1622A, UPC Number: 019348989169. n. Model Number: DYNJRA1635A, UPC Number: 019348936764.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 7 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B; h. ANGIO PACK 2-A, Model Number: DYNJ60507A; i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M; j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121; k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; l. ANGIO/PICC PACK, Model Number: DYNJ36049; m. ANGIOGRAM, Model Number: DYNJ0149444M; n. ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244; o. ANGIOGRAM TRAY, Model Number: DYNJ33638K; p. ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B; q. ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A; r. ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M; s. ANGIOGRAPHY OR, Model Number: CDS984944C; t. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G; u. ANGIOGRAPHY PACK-LF, Model Number: DYNJ0854485T; v. ANGIOPLASTY PACK-LF, Model Numbers: DYNJ43203F, DYNJ64655A; w. CATH LAB PACK, Model Number: DYNJ65185; x. CLOVIS CATH LAB PACK, Model Number: DYNJ62379; y. CUSTOM ANGIO TRAY, Model Number: DYNJ41649F; z. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367A; aa. DASHTI-YAO NEURO ANGIO-LF, Model Number: DYNJ33457C; bb. DBD-ANGIO TRAY, Model Number: DYNJ68758; cc. DBD-CATH PACK, Model Number: DYNJ63527; dd. DBD-CLOVIS CATH LAB PACK, Model Number: DYNJ62379; ee. DEPAUL ANGIO PACK, Model Number: DYNJ19939M; ff. EH VASCULAR ANGIO, Model Number: DYNJ49931F; gg. ENDOVASCULAR KIT, Model Number: DYNJ906354C; hh. EP ANGIOGRAPHY PACK, Model Number: DYNJ24225K; ii. FEMORAL ANGIOGRAPY SET UP, Model Number: DYNJ61015B; jj. FS ANGIO, Model Number: DYNJ42499C; kk. GENERAL ANGIO PACK, Model Number: DYNJ57760B; ll. HH ANGIO PACK, Model Number: DYNJ59465B; mm. IPMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0806254D; nn. IR MINOR ANGIO PACK, Model Number: DYNJ37665B; oo. KENNESTONE ANGIO, Model Number: WK100B; pp. MH HOOD CARDIAC ANGIO, Model Numbers: DYNJ49884B, DYNJ49884F; qq. MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553D; rr. OR ANGIO PACK, Model Number: DYNJ60319A; ss. OR ANGIOGRAPHY PACK, Model Number: DYNJ67245; tt. PACK,BASIC ANGIO, Model Number: DYNJ65482A; uu. PEDI ANGIO PACK-LF, Model Number: PHS41743D; vv. PEDIATRIC CATH ANGIO PACK, Model Numbers: DYNJ54755D, DYNJ54755F; ww. PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112; xx. PERCUTANEOUS ANGIO PACK-LF, Model Numbers: DYNJ57645A, DYNJ57645B; yy. PORT PACK, Model Number: DYNJ61747A; zz. SUNSHINE PACK, Model Number: DYNJ64830; aaa. SURGERY ANGIO PACK-LF, Model Number: DYNJ66500; bbb. VASCULAR ANGIO PACK-LF, Model Numbers: DYNJ0201109AG

Z-2296-2023
Recall number
Z-2296-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
63,823 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ902507B, UPC Number: 088994278118. b. Model Number: DYNJ46043D, UPC Number: 019348935036; Model Number: DYNJ46043F, UPC Number: 019348985672. c. Model Number: DYNJ43609K, UPC Number: 019348950140; Model Number: DYNJ43609L, UPC Number 019348960178; Model Number: DYNJ43609M, UPC Number 019348962744; Model Number: DYNJ43609N, UPC Number 019348928212. d. Model Number: DYNJ17624B, UPC Number: 019348986729; Model Number: DYNJ44320F, UPC Number 019348943551. e. Model Number: DYNJ47951A, UPC Number: 019348960984. f. Model Number: DYNJ40632C, UPC Number: 019348946117. g. Model Number: DYNJ30141, UPC Number: 019348956435; Model Number: DYNJ34361, UPC Number 088438934847; Model Number: DYNJ42903B, UPC Number: 088827779801; Model Number: DYNJ43661B, UPC Number 088994280870; Model Number: DYNJ47226A, UPC Number: 088827756181; Model Number: DYNJ50624A, UPC Number 088994247463; Model Number: DYNJ51239A, UPC Number: 088994249354; Model Number: DYNJ58111C, UPC Number 019348984600; Model Number: DYNJ58126A, UPC Number: 019348948475; Model Number: DYNJ62299, UPC Number 019348964151; Model Number: DYNJ62544, UPC Number: 019348966652; Model Number: DYNJ65043A, UPC Number 019348937932; Model Number: DYNJ66398A, UPC Number: 019348941416; Model Number: DYNJ66398B, UPC Number 019348989192. h. Model Number: DYNJ60507A, UPC Number: 019348983055. i. Model Number: DYNJ0373279L, UPC Number: 019348956435; Model Number: DYNJ0373279M, UPC Number: 019348951902. j. Model Number: DYNJ46153A, UPC Number: 088994218586; Model Number: DYNJ46153B, UPC Number: 019348985364; Model Number: DYNJ52121, UPC Number: 088994224362. k. Model Number: DYNJ62742, UPC Number: 019348968592, Lot Numbers: 21LBP049, 22OBH570, 22EBP081, 22FBG069, 20XBB252, 21BBH070, 21DBJ756. l. Model Number: DYNJ36049, UPC Number: 019348956435. m. Model Number: DYNJ0149444M, UPC Number: 019348956435. n. Model Number: DYNJ45007, UPC Number: 088827708541; Model Number: DYNJ47004C, UPC Number: 019348969617; Model Number: DYNJ66244, UPC Number: 019348932371. o. Model Number: DYNJ33638K, UPC Number: 019348934328. p. Model Number: DYNJ49621B, UPC Number: 088994228223; Model Number: DYNJ63060A, UPC Number: 019348942308; Model Number: DYNJ63684F, UPC Number: 019348989720; Model Number: DYNJ68065, UPC Number: 019348947511; Model Number: DYNJ68065A, UPC Number: 019348988872; Model Number: DYNJT2344B, UPC Number: 088994210780. q. Model Number: DYNJ28067G, UPC Number: 088994274429; Model Number: DYNJVB1135A, UPC Number: 019348933993. r. Model Number: 00-401318L, UPC Number: 088827709176; Model Number: 00-401318M, UPC Number: 019348934875. s. Model Number: CDS984944C, UPC Number: 088994217295. t. Model Number: DYNJ44293D, UPC Number: 019348983341; Model Number: DYNJ47906, UPC Number: 088827752837; Model Number: DYNJ55252B, UPC Number: 019348987015; Model Number: DYNJ57498, UPC Number: 088994274574; Model Number: DYNJ65190C, UPC Number: 019348943311; Model Number: DYNJ66476, UPC Number: 019348935677; Model Number: DYNJC2371G, UPC Number: 088994249467. u. Model Number: DYNJ0854485T, UPC Number: 019348986419. v. Model Number: DYNJ43203F, UPC Number: 019348939286; Model Number: DYNJ64655A, UPC Number: 019348986331. w. Model Number: DYNJ65185, UPC Number: 019348925314. x. Model Number: DYNJ62379, UPC Number: 019348965170. y. Model Number: DYNJ41649F, UPC Number: 019348964127. z. Model Number: DYNJ42367A, UPC Number: 088827794377. aa. Model Number: DYNJ33457C, UPC Number: 019348946180. bb. Model Number: DYNJ68758, UPC Number: 019348983756. cc. Model Number: DYNJ63527, UPC Number: 019348974839. dd. Model Number: DYNJ62379, UPC Number: 019348965170. ee. Model Number: DYNJ19939M, UPC Number: 019348939324. ff. Model Number: DYNJ49931F, UPC Number: 019348947166. gg. Model Number: DYNJ906354C, UPC Number: 019348981670. hh. Model Number: DYNJ24225K, UPC Number: 088994251070. ii. Model Number: DYNJ61015B, UPC Number: 019348936888. jj. Model Number: DYNJ42499C, UPC Number: 019532703086. kk. Model Number: DYNJ57760B, UPC Number: 019348934258. ll. Model Number: DYNJ59465B, UPC Number: 019348947093. mm. Model Number: DYNJ0806254D, UPC Number: 088994247116. nn. Model Number: DYNJ37665B, UPC Number: 088994296973. oo. Model Number: WK100B, UPC Number: 019348934875. pp. Model Number: DYNJ49884B, UPC Number: 088994236366; Model Number: DYNJ49884F, UPC Number: 019348946957. qq. Model Number: DYNJ41553D, UPC Number: 088994281133. rr. Model Number: DYNJ60319A, UPC Number: 019348927629. ss. Model Number: DYNJ67245, UPC Number: 019348939305. tt. Model Number: DYNJ65482A, UPC Number: 019348941682. uu. Model Number: PHS41743D, UPC Number: 019348945327. vv. Model Number: DYNJ54755D, UPC Number: 019348943426; Model Number: DYNJ54755F, UPC Number: 019348988460. ww. Model Number: DYNJ60112, UPC Number: 088827779984. xx. Model Number: DYNJ57645A, UPC Number: 019348955794; Model Number: DYNJ57645B, UPC Number: 019348982865. yy. Model Number: DYNJ61747A, UPC Number: 019348971965. zz. Model Number: DYNJ64830, UPC Number: 019348922313. aaa. Model Number: DYNJ66500, UPC Number: 019348935791. bbb. Model Number: DYNJ0201109AG, UPC Number: 019348949726.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 8 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125; i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B; j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325; k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335; m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160; n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560; o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075; q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055; r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US; t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470; v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170; w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545; x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B; y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350; z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475; bb. 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770; cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370; dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910; ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905; ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795; gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705; hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355; ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640; jj. ABLATION EP PACK, Model Number: DYNJ43851B; kk. ABLATION PACK, Model Number: DYNJ40629C; ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N; mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B; nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S; oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X; pp. ANGIO CATH PACK, Model Number: DYNJ52000B; qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J; rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F; ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D; tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951; uu. ANGIO PACK-LF, Model Number: DYNJ0407399P; vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944; ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A; xx. ANGIO/PICC PACK, Model Number: DYNJ36049A; yy. ANGIOGRAM, Model Number: DYNJ0149444N; zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A; aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G; bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A; ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V; ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J; eee

Z-2297-2023
Recall number
Z-2297-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
97,677 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ908249A, UPC Number: 019532724050. b. Model Number: ECVC7410A, UPC Number: 10653160353645. c. Model Number: ECVC2205A, UPC Number: 10653160357148. d. Model Number: ECVC8095, UPC Number: 10653160357759. e. Model Number: ECVC5010A, UPC Number: 10653160335290. f. Model Number: ECVC6800A, UPC Number: 10653160355694. g. Model Number: ECVC2555, UPC Number: 10653160336570. h. Model Number: ECVC4125, UPC Number: 10653160339502. i. Model Number: ECVC5135B, UPC Number: 10653160353652. j. Model Number: ECVC7325, UPC Number: 10653160345589. k. Model Number: ECVC1970B, UPC Number: 10653160357155. l. Model Number: ECVC4335, UPC Number: 10653160357285. m. Model Number: ECVC7160, UPC Number: 10653160335306. n. Model Number: ECVC2560, UPC Number: 10653160334286. o. Model Number: ECVC3505, UPC Number: 10653160334767. p. Model Number: ECVC7075, UPC Number: 10653160335122. q. Model Number: ECVC8055, UPC Number: 10653160355656. r. Model Number: ECVC8165, UPC Number: 10653160358749. s. Model Number: ECVC4635A, UPC Number: 10653160352112; Model Number: ECVC7040A, UPC Number: 10653160344414; Model Number: ECVC7430, UPC Number: 10653160346524; Model Number: ECVC7475, UPC Number: 10653160347569; Model Number: ECVC7605, UPC Number: 10653160347743; Model Number: ECVC7675, UPC Number: 10653160348122; Model Number: ECVC8005, UPC Number: 10653160355137; Model Number: ECVC8130, UPC Number: 10653160358343; Model Number: STCVC2055US, UPC Number: 10653160355564. t. Model Number: ECVC7600, UPC Number: 10653160347736. u. Model Number: ECVC4640A, UPC Number: 10653160352105; Model Number: ECVC6490A, UPC Number: 10653160344360; Model Number: ECVC6845, UPC Number: 10653160339366; Model Number: ECVC7470, UPC Number: 10653160347583. v. Model Number: ECVC6170, UPC Number: 10653160333395. w. Model Number: ECVC3545, UPC Number: 10653160334774. x. Model Number: ECVC2440B, UPC Number: 10653160358930. y. Model Number: ECVC7350, UPC Number: 10653160346265. z. Model Number: ECVC5480, UPC Number: 10653160339458. aa. Model Number: ECVC3475, UPC Number: 10653160334736. bb. Model Number: ECVC2770, UPC Number: 10653160332671. cc. Model Number: ECVC6370, UPC Number: 10653160333425. dd. Model Number: ECVC7910, UPC Number: 10653160357254. ee. Model Number: ECVC7235, UPC Number: 10653160341703; Model Number: ECVC7905, UPC Number: 10653160356912. ff. Model Number: ECVC2795, UPC Number: 10653160334200. gg. Model Number: ECVC705, UPC Number: 10653160331889. hh. Model Number: ECVC7355, UPC Number: 10653160346272. ii. Model Number: ECVC6640, UPC Number: 10653160333494. jj. Model Number: DYNJ43851B, UPC Number: 019532720032. kk. Model Number: DYNJ40629C, UPC Number: 019348999731. ll. Model Number: DYNJ23455K, UPC Number: 019348956435; Model Number: DYNJ23455L, UPC Number: 019348956435; Model Number: DYNJ23455M, UPC Number: 019348956435; Model Number: DYNJ23455N, UPC Number: 019532723775. mm. Model Number: DYNJ902507C, UPC Number: 019532713788; Model Number: DYNJ905151B, UPC Number: 019532721996. nn. Model Number: DYNJ43609O, UPC Number: 019348946871; Model Number: DYNJ43609P, UPC Number: 019348991453; Model Number: DYNJ43609R, UPC Number: 019532722878; Model Number: DYNJ43609S, UPC Number: 019532732298. oo. Model Number: DYNJ0313233V, UPC Number: 019348956435; Model Number: DYNJ0313233W, UPC Number: 019348956435; Model Number: DYNJ0313233X, UPC Number: 019532725098. pp. Model Number: DYNJ52000B, UPC Number: 019348938498. qq. Model Number: DYNJ44320G, UPC Number: 019348996630; Model Number: DYNJ44320I, UPC Number: 019532707035; Model Number: DYNJ44320J, UPC Number: 019532713235. rr. Model Number: DYNJ47665D, UPC Number: 019348995282; Model Number: DYNJ47665F, UPC Number: 019532735521. ss. Model Number: DYNJ0037936C, UPC Number: 019348956435; Model Number: DYNJ0037936D, UPC Number: 019532712953. tt. Model Number: DYNJ42903C, UPC Number: 019532707966; Model Number: DYNJ42903D, UPC Number: 019532717111; Model Number: DYNJ43661C, UPC Number: 019532710435; Model Number: DYNJ44642B, UPC Number: 019532701142; Model Number: DYNJ58111D, UPC Number: 019348993292; Model Number: DYNJ58111F, UPC Number: 019532722351; Model Number: DYNJ69200, UPC Number: 019348990681; Model Number: DYNJ69951, UPC Number: 019532700030. uu. Model Number: DYNJ0407399P, UPC Number: 019532733686. vv. Model Number: DYNJ69944, UPC Number: 019348999845. ww. Model Number: DYNJ23438M, UPC Number: 019348997060; Model Number: DYNJ52121A, UPC Number: 019532726009; Model Number: DYNJ69421, UPC Number: 019348993759; Model Number: DYNJ69792, UPC Number: 019348997928; Model Number: DYNJ82999, UPC Number: 019532722310; Model Number: DYNJ82999A, UPC Number: 019532731027. xx. Model Number: DYNJ36049A, UPC Number: 019532714720. yy. Model Number: DYNJ0149444N, UPC Number: 019348996671. zz. Model Number: DYNJ67320A, UPC Number: 019348993757. aaa. Model Number: 00-400305R, UPC Number: 019348994428; Model Number: DYNJ49621C, UPC Number: 019532700858; Model Number: DYNJ63060B, UPC Number: 019348991282; Model Number: DYNJ63684G, UPC Number: 019532703722; Model Number: DYNJ68065B, UPC Number: 019532701333. bbb. Model Number: DYNJ44293F, UPC Number: 019532726518; Model Number: DYNJ45059B, UPC Number: 088994213563; Model Number: DYNJ55252C, UPC Number: 019532726791; Model Number: DYNJ65190D, UPC Number: 019532706664; Model Number: DYNJ65190F, UPC Number: 019532709265; Model Number: DYNJ66476A, UPC Number: 019532705189; Model Number: DYNJ67144A, UPC Number: 019532717902. ccc. Model Number: DYNJ0290716M, UPC Number: 019532708886; Model Number: DYNJ0854485V, UPC Number: 019532709688. ddd. Model Number: DYNJ44700J, UPC Number: 019532727741. eee. Model Number: DYNJ43203G, UPC Number: 019348995291; Model Number: DYNJ64655B, UPC Number: 019348996101; Model Number: DYNJ64655C, UPC Number: 019532717289. fff. Model Number: DYNJ43261J, UPC Number: 019532728879; Model Number: DYNJ52774, UPC Number: 088994232247; Model Number: DYNJ53095, UPC Number: 088994237177; Model Number: DYNJ55169D, UPC Number: 019348972168; Model Number: DYNJ55169F, UPC Number: 019348984849. ggg. Model Number: DYNJ62733A, UPC Number: 019348997067. hhh. Model Number: ECVC7840A, UPC Number: 10653160355427. iii. Model Number: STCVC12US, UPC Number: 10653160311829. jjj. Model Number: ECVC3440, UPC Number: 10653160332770. kkk. Model Number: ECVC5640A, UPC Number: 10653160339977. lll. Model Number: ECVC7875, UPC Number: 10653160351535. mmm. Model Number: ECVC5860, UPC Number: 10653160341543. nnn. Model Number: ECVC5615, UPC Number: 10653160341512. ooo. Model Number: ECVC5665, UPC Number: 10653160341505. ppp. Model Number: ECVC4300, UPC Number: 10653160334873. qqq. Model Number: ECVC2600, UPC Number: 10653160334279. rrr. Model Number: ECVC3210, UPC Number: 10653160334071. sss. Model Number: ECVC7070B, UPC Number: 10653160346166. ttt. Model Number: DYNJV0177AF, UPC Number: 019348926312. uuu. Model Number: DYNJ41700A, UPC Number: 088994275695. vvv. Model Number: DYNJ907014A, UPC Number: 019348947402. www. Model Number: DYNJ38866D, UPC Number: 019348956435; Model Number: DYNJ38866F, UPC Number: 019348991486; Model Number: DYNJ67174A, UPC Number: 019532704680; Model Number: DYNJ67174B, UPC Number: 019532713108; Model Number: DYNJ82280, UPC Number: 019532718392; Model Number: DYNJ82296, UPC Number: 019532718420. xxx. Model Number: DYNJ0842644F, UPC Number: 019532728860; Model Number: DYNJ0855138P, UPC Number: 019348956435; Model Number: DYNJ0855138Q, UPC Number: 019532709484; Model Number: DYNJ42996C, UPC Number: 019348998843. yyy. Model Number: DYNJ45323F, UPC Number: 019532708236. zzz. Model Number: ECVC2660, UPC Number: 10653160338178. aaaa. Model Number: DYNJ64050A, UPC Number: 019348994382; Model Number: DYNJ63684G, UPC Number: 019532703722. bbbb. Model Number: DYNJ66182, UPC Number: 019348932098. cccc. Model Number: DYNJ33709F, UPC Number: 088994271392. dddd. Model Number: DYNJ33739G, UPC Number: 088994271393. eeee. Model Number: DYNJ55680A, UPC Number: 088994263978. ffff. Model Number: DYNJ68763, UPC Number: 019348983759; Model Number: DYNJ68763A, UPC Number: 019532726478. gggg. Model Number: DYNJ69864, UPC Number: 019348999048. hhhh. Model Number: DYNJ40926A, UPC Number: 019532713721; Model Number: DYNJ55455A, UPC Number: 019348938623; Model Number: DYNJ60763, UPC Number: 019348952796; Model Number: DYNJ66166A, UPC Number: 019348939599. iiii. Model Number: DYNJ67895, UPC Number: 019348945396. jjjj. Model Number: DYNJ57723B, UPC Number: 019348951627. kkkk. Model Number: DYNJ80269, UPC Number: 019532701780. llll. Model Number: DYNJ60329, UPC Number: 088994297098. mmmm. Model Number: DYNJ51338C, UPC Number: 019348924171; Model Number: DYNJ56547C, UPC Number: 019348987983; Model Number: DYNJ59632D, UPC Number: 019532703407; Model Number: DYNJ63181A, UPC Number: 019532704548; Model Number: DYNJ63181B, UPC Number: 019532712721; Model Number: DYNJ63181C, UPC Number: 019532724200; Model Number: DYNJ66473A, UPC Number: 019348991777; Model Number: DYNJ83089, UPC Number: 019532723083; Model Number: DYNJ83105, UPC Number: 019532723151. nnnn. Model Number: ECVC6970, UPC Number: 10653160336693. oooo. Model Number: ECVC360, UPC Number: 10653160332855. pppp. Model Number: ECVC3285, UPC Number: 10653160336105. qqqq. Model Number: ECVC2745, UPC Number: 10653160334224. rrrr. Model Number: ECVC2750, UPC Number: 10653160334217. ssss. Model Number: ECVC1140A, UPC Number: 10653160331964. tttt. Model Number: ECVC2300, UPC Number: 10653160334330. uuuu. Model Number: ECVC2305, UPC Number: 10653160332473. vvvv. Model Number: ECVC1345A, UPC Number: 10653160334606. wwww. Model Number: ECVC1725, UPC Number: 10653160334507. xxxx. Model Number: DYNJ81316, UPC Number: 019532710379. yyyy. Model Number: ECVC5530A, UPC Number: 10653160345596. zzzz. Model Number: DYNJ61082C, UPC Number: 019532711141; Model Number: DYNJ61082D, UPC Number: 019532726199. aaaaa. Model Number: DYNJ0378596I, UPC Number: 10195327188818; Model Number: DYNJ0378596J, UPC Number: 10195327310608.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 9 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A; h. CVC BUNDLE, Model Number: ECVC3235; i. CVC BUNDLE 16CM, Model Number: ECVC2335; j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B; k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B; l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460; m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A; n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001; o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A; p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: ECVC7200; q. CVC BUNDLE KIT OR, Model Number: ECVC2205; r. CVC BUNDLE KIT STANDARD, Model Number: ECVC1970A; s. CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; t. CVC BUNDLE VANTEX 7FR, 20CM, 3L, Model Number: ECVC6120; u. CVC BUNDLE, 20CM, 7FR, 3L, Model Number: ECVC6150; v. CVC BUNLDE 4L 20CM, Model Number: ECVC5095B; w. CVC DOUBLE LUMEN 16CM, Model Numbers: ECVC5585A, ECVC5585B, ECVC8105; x. CVC HEART PACK, Model Number: ECVC7360; y. CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number: ECVC3755A; z. CVC INSERT BUNDLE 16CM, Model Number: ECVC3260, ECVC7860; aa. CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number: ECVC2895; bb. CVC INSERTION BUNDLE - MULTIMED, Model Number: ECVC5315; cc. CVC INSERTION BUNDLE - VANTEX, Model Number: ECVC5310; dd. CVC INSERTION BUNDLE 20 CM, Model Number: ECVC1555; ee. CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number: ECVC3286; ff. CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number: ECVC3285A; gg. CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number: ECVC5560A; hh. CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; ii. CVC INSERTION BUNDLE W/CATHETER, Model Number: ECVC1525; jj. CVC INSERTION BUNDLE, 20CM, Model Number: ECVC6850; kk. CVC INSERTION MAX BUNDLE 20CM, Model Number: ECVC5525A; ll. CVC INSERTION TRAY 16 CM, Model Number: ECVC1300; mm. CVC KIT WITH CATHETER, Model Number: ECVC885; nn. CVC QUAD-LUMEN PERSONAL PROTECTION KIT, Model Number: ECVC105; oo. CVC TRIPLE LUMEN 16CM, Model Number: ECVC5590B; pp. CVC TRIPLE LUMEN 20CM BUNDLE, Model Number: ECVC2235; qq. CVC TRIPLE LUMEN 7FR 16 CM VANTEX, Model Numbers: ECVC6015A, ECVC6015B; rr. CVC TRIPLE LUMEN 7FR 20CM VANTEX, Model Numbers: ECVC5985A, ECVC5985B; ss. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC400; tt. CVC TRIPLE LUMEN KIT, Model Number: ECVC465; uu. CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC6070; vv. CVC ZONE DEFENSE BUNDLE, Model Numbers: ECVC5385, ECVC6940; ww. DBD-ANGIO DRAPE PACK, Model Number: DYNJ44320J; xx. DBD-CARDIAC EP PACK-LF, Model Number: DYNJ0429185L; yy. DBD-CATH/ANGIO II-LF, Model Number: DYNJ80297; zz. DBD-CRMC TUNNEL CATH TRAY-LF, Model Number: DYNJ61118D; aaa. DBD-CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; bbb. DBD-PERIPHERAL CATHETER 668236-V, Model Number: DYNJ58510A; ccc. DBD-PICC LINE INSERTION PACK, Model Number: DYNJ42531; ddd. DBD-REGIONAL CATHETER KIT, Model Number: PAIN1336; eee. DIALYSIS CATH INSERTION PK-LF, Model Number: DYNJ0198765G; fff. DIALYSIS TRAY, Model Number: DYNJ43060B; ggg. DRAINAGE PROCEDURE PACK, Model Number: DYNJ67149A; hhh. DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number: ECVC4985; iii. DUAL INSERTION CVC + SHEATH BUNDLE, Model Number: ECVC2940; jjj. ECMO PACK 2, Model Number: DYNJ82079; kkk. ENDOVASCULAR PACK, Model Number: DYNJ69691; lll. EP DRAPE PACK-LF, Model Number: DYNJ47645B; mmm. EPS PACK, Model Number: DYNJ46545C; nnn. EV LAB PACK, Mo

Z-2298-2023
Recall number
Z-2298-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
76,870 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ61099B, UPC Number: 019532711185; Model Number: DYNJ61099C, UPC Number: 019532726200. b. Model Number: DYNJ61118C, UPC Number: 019348946397; Model Number: DYNJ61118F, UPC Number: 019532726198. c. Model Number: DYNJ41649G, UPC Number: 019532727729. d. Model Number: ECVC2595, UPC Number: 10653160332596. e. Model Number: CDS984100U, UPC Number: 019532714613; Model Number: CDS984100V, UPC Number: 019532725205. f. Model Number: ECVC2225, UPC Number: 10653160334385. g. Model Number: ECVC7265A, UPC Number: 10653160345145. h. Model Number: ECVC3235, UPC Number: 10653160336112. i. Model Number: ECVC2335, UPC Number: 10653160332497. j. Model Number: ECVC5120B, UPC Number: 10653160333180. k. Model Number: ECVC5095B, UPC Number: 10653160333173. l. Model Number: ECVC6075, UPC Number: 10653160338437; Model Number: ECVC6460, UPC Number: 10653160335085. m. Model Number: ECVC2240A, UPC Number: 10653160334361. n. Model Number: ECVC2001, UPC Number: 10653160334415. o. Model Number: ECVC7205A, UPC Number: 10653160342007. p. Model Number: ECVC7200, UPC Number: 10653160341680. q. Model Number: ECVC2205, UPC Number: 10653160332435. r. Model Number: ECVC1970A, UPC Number: 10653160346159. s. Model Number: ECVC5540A, UPC Number: 10653160335009. t. Model Number: ECVC6120, UPC Number: 10653160336532. u. Model Number: ECVC6150, UPC Number: 10653160335054. v. Model Number: ECVC5095B, UPC Number: 10653160333173. w. Model Number: ECVC5585A, UPC Number: 10653160333326; Model Number: ECVC5585B, UPC Number: 10653160357711; Model Number: ECVC8105, UPC Number: 10653160357858. x. Model Number: ECVC7360, UPC Number: 10653160346289. y. Model Number: ECVC3755A, UPC Number: 10653160334804. z. Model Number: ECVC3260, UPC Number: 10653160331704; Model Number: ECVC7860, UPC Number: 10653160351191. aa. Model Number: ECVC2895, UPC Number: 10653160332725. bb. Model Number: ECVC5315, UPC Number: 10653160339465. cc. Model Number: ECVC5310, UPC Number: 10653160336211. dd. Model Number: ECVC1555, UPC Number: 10653160331759. ee. Model Number: ECVC3286, UPC Number: 10653160358398. ff. Model Number: ECVC3285A, UPC Number: 10653160358572. gg. Model Number: ECVC5560A, UPC Number: 10653160336501. hh. Model Number: ECVC6355, UPC Number: 10653160336396. ii. Model Number: ECVC1525, UPC Number: 10653160334545. jj. Model Number: ECVC6850, UPC Number: 10653160338819. kk. Model Number: ECVC5525A, UPC Number: 10653160338130. ll. Model Number: ECVC1300, UPC Number: 10653160331780. mm. Model Number: ECVC885, UPC Number: 10653160333562. nn. Model Number: ECVC105, UPC Number: 10653160331773. oo. Model Number: ECVC5590B, UPC Number: 10653160357728. pp. Model Number: ECVC2235, UPC Number: 10653160334378. qq. Model Number: ECVC6015A, UPC Number: 10653160335146; Model Number: ECVC6015B, UPC Number: 10653160357704. rr. Model Number: ECVC5985A, UPC Number: 10653160333371; Model Number: ECVC5985B, UPC Number: 10653160357797. ss. Model Number: ECVC400, UPC Number: 10653160331827. tt. Model Number: ECVC465, UPC Number: 10653160333074. uu. Model Number: ECVC6070, UPC Number: 10653160335863. vv. Model Number: ECVC5385, UPC Number: 10653160336518; Model Number: ECVC6940, UPC Number: 10653160336709. ww. Model Number: DYNJ44320J, UPC Number: 019532713235. xx. Model Number: DYNJ0429185L, UPC Number: 019532704897. yy. Model Number: DYNJ80297, UPC Number: 019532702177. zz. Model Number: DYNJ61118D, UPC Number: 019532710821. aaa. Model Number: DYNJ41649G, UPC Number: 019532727729. bbb. Model Number: DYNJ58510A, UPC Number: 019348981743. ccc. Model Number: DYNJ42531, UPC Number: 088438992673. ddd. Model Number: PAIN1336, UPC Number: 019348951153. eee. Model Number: DYNJ0198765G, UPC Number: 088994205398. fff. Model Number: DYNJ43060B, UPC Number: 088994276585. ggg. Model Number: DYNJ67149A, UPC Number: 019532717903. hhh. Model Number: ECVC4985, UPC Number: 10653160335269. iii. Model Number: ECVC2940, UPC Number: 10653160335351. jjj. Model Number: DYNJ82079, UPC Number: 019532716736. kkk. Model Number: DYNJ69691, UPC Number: 019348997011. lll. Model Number: DYNJ47645B, UPC Number: 019348995283. mmm. Model Number: DYNJ46545C, UPC Number: 019532725042. nnn. Model Number: DYNJ53481D, UPC Number: 019348981257. ooo. Model Number: DYNJ44334M, UPC Number: 019532713311; Model Number: DYNJ44334N, UPC Number: 019532729949. ppp. Model Number: CDS982998C, UPC Number: 019348927943; Model Number: CDS982998D, UPC Number: 019348992377; Model Number: CDS982998F, UPC Number: 019532712690. qqq. Model Number: DYNJ909393, UPC Number: 019532733558. rrr. Model Number: DYNJ66515A, UPC Number: 019348940616. sss. Model Number: ECVC2320, UPC Number: 10653160332480. ttt. Model Number: ECVC2720, UPC Number: 10653160332657. uuu. Model Number: DYNJ57760C, UPC Number: 019532707939. vvv. Model Number: DYNJ65174D, UPC Number: 019348996215. www. Model Number: DYNJ69298, UPC Number: 019348992541. xxx. Model Number: DYNJ57049G, UPC Number: 019532711039; Model Number: DYNJ57049I, UPC Number: 019532720773. yyy. Model Number: DYNJ81213, UPC Number: 019532709427. zzz. Model Number: SYNJ10303C, UPC Number: 019532711889. aaaa. Model Number: DYNJ60343B, UPC Number: 019532721549; Model Number: DYNJ60343C, UPC Number: 019532728504. bbbb. Model Number: DYNJ50694A, UPC Number: 088994269351. cccc. Model Number: DYNJ40215B, UPC Number: 088827791226. dddd. Model Number: ECVC3705, UPC Number: 10653160332893. eeee. Model Number: ECVC1915, UPC Number: 10653160334446. ffff. Model Number: ECVC1915, UPC Number: 10653160334446. gggg. Model Number: STCVC09US, UPC Number: 10653160342939. hhhh. Model Number: STCVC10US, UPC Number: 10653160343097. iiii. Model Number: ECVC6265, UPC Number: 10653160342922. jjjj. Model Number: DYNJ50712D, UPC Number: 019532726792. kkkk. Model Number: DYNJ64976, UPC Number: 019348923712. llll. Model Number: DYNJ36752B, UPC Number: 019532722602; Model Number: DYNJ41989F, UPC Number: 088994276885; Model Number: DYNJ41989G, UPC Number: 019348931080; Model Number: DYNJ61646A, UPC Number: 019532701431; Model Number: DYNJ62037C, UPC Number: 019348921283; Model Number: DYNJ62037D, UPC Number: 019348989369; Model Number: DYNJ67737, UPC Number: 019348942775; Model Number: DYNJ68538, UPC Number: 019348983311; Model Number: DYNJ68729B, UPC Number: 019532702091. mmmm. Model Number: DYNJ66926, UPC Number: 019348938796; Model Number: DYNJ66926A, UPC Number: 019348988735. nnnn. Model Number: DYNJ0950839C, UPC Number: 088994210129. oooo. Model Number: DYNJ69056, UPC Number: 019348988687; Model Number: DYNJ69056A, UPC Number: 019532706129. pppp. Model Number: DYNJ36738G, UPC Number: 019532705416. qqqq. Model Number: ECVC6555, UPC Number: 10653160336341. rrrr. Model Number: DYNJ35164C, UPC Number: 088994249466. ssss. Model Number: DYNJ0537652AG, UPC Number: 019532701767. tttt. Model Number: DYNJ61373A, UPC Number: 019532701469. uuuu. Model Number: ECVC5855B, UPC Number: 10653160355113. vvvv. Model Number: DYNJ52425K, UPC Number: 019532704235; Model Number: DYNJ52425L, UPC Number: 019532707448; Model Number: DYNJ52425M, UPC Number: 019532717718; Model Number: DYNJ52425N, UPC Number: 019532733932. wwww. Model Number: DYNJ69898, UPC Number: 019348999389. xxxx. Model Number: DYNJ38326D, UPC Number: 019348956435; Model Number: DYNJ38326G, UPC Number: 019532723013. yyyy. Model Number: ECVC2650, UPC Number: 10653160334248. zzzz. Model Number: ECVC7095, UPC Number: 10653160339236.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 10 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810

Z-2299-2023
Recall number
Z-2299-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
104,755 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC475, UPC Number: 10653160333081. b. Model Number: ECVC3900, UPC Number: 10653160334828. c. Model Number: STCVC20US, UPC Number: 10653160339076. d. Model Number: STCVC21US, UPC Number: 10653160339045. e. Model Number: ECVC6585A, UPC Number: 10653160338826. f. Model Number: ECVC7235A, UPC Number: 10653160354550. g. Model Number: STCVC03US, UPC Number: 10653160339212. h. Model Number: ECVC6655A, UPC Number:10653160339267. i. Model Number: ECVC7935, UPC Number: 10653160353669. j. Model Number: STCVC04US, UPC Number: 10653160339199. k. Model Number: ECVC7670, UPC Number:10653160348054. l. Model Number: ECVC7090, UPC Number: 10653160339243. m. Model Number: ECVC6930, UPC Number:10653160339250. n. Model Number: STCVC13US, UPC Number: 10653160339137. o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712. p. Model Number: ECVC8010, UPC Number: 10653160356356. q. Model Number: ECVC4615, UPC Number: 10653160336075. r. Model Number: DYNJ59184B, UPC Number: 019348994910. s. Model Number: DYNJ909267, UPC Number: 019532731461. t. Model Number: DYNJ906297D, UPC Number: 019532714128. u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222. v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047. w. Model Number: ECVC6665, UPC Number: 10653160337843. x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001. y. Model Number: DYNJ65481, UPC Number: 019348928046. z. Model Number: DYNJ60112B, UPC Number: 019532711884. aa. Model Number: DYNJ54755G, UPC Number: 019348998776; Model Number: DYNJ54755I, UPC Number: 019532702126. bb. Model Number: DYNJ0843244K, UPC Number: 019532728859. cc. Model Number: DYNJ57645C, UPC Number:019532728741. dd. Model Number: DYNJ46035C, UPC Number: 019348934095; Model Number: DYNJ46035D, UPC Number: 019348949364. ee. Model Number: DYNJ62007A, UPC Number: 019348987890. ff. Model Number: ECVC3665, UPC Number: 10653160336044. gg. Model Number: ECVC6190, UPC Number: 10653160337751. hh. Model Number: ECVC4380, UPC Number: 10653160338147. ii. Model Number: ECVC5655, UPC Number: 10653160337621. jj. Model Number: ECVC5650, UPC Number: 10653160336457. kk. Model Number: ECVC5660, UPC Number: 10653160337638. ll. Model Number: ECVC5685, UPC Number: 10653160337652. mm. Model Number: DYNJ0275614F, UPC Number: 088994217434. nn. Model Number: DYNJ43894B, UPC Number: 019348981048. oo. Model Number: DYNJ59307F, UPC Number: 019532705885. pp. Model Number: DYNJ58162, UPC Number: 088994282933. qq. Model Number: DYNJ51240A, UPC Number: 088994249352. rr. Model Number: ECVC3700, UPC Number: 10653160332886. ss. Model Number: ECVC4995, UPC Number: 10653160335283. tt. Model Number: ECVC5025, UPC Number: 10653160333142; Model Number: ECVC4135, UPC Number: 10653160335900. uu. Model Number: ECVC5820, UPC Number: 10653160338123. vv. Model Number: DYNJ65913, UPC Number: 019348930317. ww. Model Number: DYNJ41190, UPC Number: 088438989908; Model Number: DYNJ43894A, UPC Number: 088994213269; Model Number: DYNJ44087A, UPC Number: 088994256180; Model Number: DYNJ44524F, UPC Number: 019348946748; Model Number: DYNJ52806C, UPC Number: 019348929290. xx. Model Number: DYNJVB1000, UPC Number: 019348980099. yy. Model Number: DYNJ69742, UPC Number: 019348997490; Model Number: DYNJ69742B, UPC Number: 019532713688. zz. Model Number: ECVC2930, UPC Number: 10653160335368; Model Number: ECVC5835, UPC Number: 10653160333364. aaa. Model Number: DYNJ82030, UPC Number: 019532716237. bbb. Model Number: DYNJ82041, UPC Number: 019532716221. ccc. Model Number: DYNJ68729, UPC Number: 019348983654. ddd. Model Number: DYNJ38314G, UPC Number: 019348960334. eee. Model Number: DYNJ0416535AA, UPC Number: 019532735459; Model Number: DYNJ0416535W, UPC Number: 019348956435; Model Number: DYNJ0458661C, UPC Number: 088994255094. fff. Model Number: DYNJ0604508R, UPC Number: 019348982844. ggg. Model Number: DYNJ23288C, UPC Number: 019348995414. hhh. Model Number: DYNJ67136A, UPC Number: 019348993567. iii. Model Number: ECVC7465A, UPC Number: 10653160350088. jjj. Model Number: ECVC8100, UPC Number: 10653160357841. kkk. Model Number: DYNJ27613J, UPC Number: 019348956435; Model Number: DYNJ27613K, UPC Number: 019532713118. lll. Model Number: DYNJ80925, UPC Number: 019532708511. mmm. Model Number: DYNJ52425J, UPC Number: 019348994014. nnn. Model Number: DYNJ83251, UPC Number: 019532724865. ooo. Model Number: ECVC7310, UPC Number: 10653160345060; Model Number: ECVC7310A, UPC Number: 10653160352792. ppp. Model Number: ECVC2965, UPC Number: 10653160338611; Model Number: ECVC3155, UPC Number: 10653160334132; Model Number: ECVC5475, UPC Number: 10653160338116. qqq. Model Number: ECVC5015, UPC Number: 10653160338956. rrr. Model Number: ECVC3395, UPC Number: 10653160338635. sss. Model Number: ECVC5810, UPC Number: 10653160336419. ttt. Model Number: ECVC255, UPC Number: 10653160331735; Model Number: ECVC5200, UPC Number: 10653160336150. uuu. Model Number: ECVC825A, UPC Number: 10653160333548. vvv. Model Number: ECVC7180, UPC Number: 10653160343165. www. Model Number: ECVC7425, UPC Number: 10653160347699; Model Number: STCVC2040, UPC Number: 10653160336785; Model Number: STCVC2040A, UPC Number: 10653160345701. xxx. Model Number: ECVC7290, UPC Number: 10653160344933. yyy. Model Number: ECVC5355B, UPC Number: 10653160357742. zzz. Model Number: ECVC6020A, UPC Number: 10653160338413. aaaa. Model Number: ECVC1910, UPC Number:10653160334453; Model Number: ECVC5870A, UPC Number:10653160338383. bbbb. Model Number: ECVC6055A, UPC Number: 10653160335849. cccc. Model Number: ECVC6540, UPC Number: 10653160339397. dddd. Model Number: ECVC3735A, UPC Number: 10653160334798. eeee. Model Number: ECVC3355, UPC Number: 10653160333982; Model Number: ECVC3400, UPC Number: 10653160340591; Model Number: ECVC3460, UPC Number: 10653160332794; Model Number: ECVC3785, UPC Number: 10653160336006; Model Number: ECVC3810, UPC Number: 10653160336013; Model Number: ECVC4880, UPC Number: 10653160333111; Model Number: ECVC5020, UPC Number: 10653160334903; Model Number: ECVC5020A, UPC Number: 10653160358251; Model Number: ECVC5125, UPC Number: 10653160334934; Model Number: ECVC5270, UPC Number: 10653160336198; Model Number: ECVC6395, UPC Number: 10653160336372. ffff. Model Number: ECVC1490, UPC Number: 10653160332183; Model Number: ECVC1490A, UPC Number: 10653160359036; Model Number: ECVC1495, UPC Number: 10653160334569; Model Number: ECVC1495A, UPC Number: 10653160358794. gggg. Model Number: ECVC1710, UPC Number: 10653160332268. hhhh. Model Number: ECVC5815, UPC Number: 10653160336402. iiii. Model Number: DYNJ67990A, UPC Number: 019532726533. jjjj.Model Number: DYNJ41562F, UPC Number: 019348964108. kkkk. Model Number: DYNJ41562D, UPC Number: 019348958812. llll. Model Number: ECVC1655, UPC Number: 10653160254935. mmmm. Model Number: ECVC7170, UPC Number: 10653160333524. nnnn. Model Number: ECVC6680, UPC Number: 10653160337867; Model Number: ECVC6680A, UPC Number: 10653160337164. oooo. Model Number: ECVC6675, UPC Number: 10653160337850; Model Number: ECVC6675A, UPC Number: 10653160336617. pppp. Model Number: ECVC7970, UPC Number: 10653160353980. qqqq. Model Number: ECVC6815, UPC Number: 10653160335115. rrrr. Model Number: ECVC6840, UPC Number: 10653160336761. ssss. Model Number: ECVC6835, UPC Number: 10653160336778. tttt. Model Number: ECVC7485, UPC Number: 10653160354802. uuuu. Model Number: ECVC7615, UPC Number: 10653160348009; Model Number: ECVC7690, UPC Number: 10653160348153. vvvv. Model Number: ECVC6630, UPC Number: 10653160337492. wwww. Model Number: ECVC6690, UPC Number: 10653160336600. xxxx. Model Number: ECVC8135, UPC Number: 10653160358558; Model Number: ECVC8160, UPC Number: 10653160358404. yyyy. Model Number: ECVC7915, UPC Number: 10653160353355. zzzz. Model Number: ECVC6550, UPC Number: 10653160335276; Model Number: ECVC6595, UPC Number: 10653160337485; Model Number: ECVC7115B, UPC Number: 10653160350279; Model Number: ECVC7275, UPC Number: 10653160342700; Model Number: ECVC7275A, UPC Number: 10653160344292; Model Number: ECVC8015, UPC Number: 10653160355366. aaaaa. Model Number: ECVC7400, UPC Number: 10193489199956; Model Number: ECVC7960, UPC Number: 10653160353881; Model Number: ECVC8050, UPC Number: 10653160355601. bbbbb. Model Number: ECVC7945, UPC Number: 10653160353966. ccccc. Model Number: ECVC7625, UPC Number: 10653160356295. ddddd. Model Number: ECVC7895, UPC Number: 10653160355328. eeeee. Model Number: STCVC02US, UPC Number: 10653160336815; Model Number: STCVC02UST, UPC Number: 10653160358589. fffff. Model Number: ECVC7405, UPC Number: 10653160347132. ggggg. Model Number: ECVC7295, UPC Number: 10653160344650. hhhhh. Model Number: ECVC6765, UPC Number: 10653160336839. iiiii. Model Number: ECVC7495B, UPC Number: 10653160355748. jjjjj. Model Number: ECVC6505, UPC Number: 10653160336327; Model Number: ECVC7300, UPC Number: 10653160344698. kkkkk. Model Number: ECVC7560, UPC Number: 10653160347705; Model Number: ECVC7955, UPC Number: 10653160353867; Model Number: ECVC8020, UPC Number: 10653160355458; Model Number: ECVC8045, UPC Number: 10653160355595; Model Number: ECVC8085, UPC Number: 10653160356905. lllll. Model Number: ECVC8025, UPC Number: 10653160355434. mmmmm. Model Number: ECVC8040, UPC Number: 10653160355700. nnnnn. Model Number: ECVC7565, UPC Number: 10653160347682. ooooo. Model Number: ECVC7830A, UPC Number: 10653160355342. ppppp. Model Number: STCVC01US, UPC Number: 10653160336846; Model Number: STCVC01UST, UPC Number: 10653160358565. qqqqq. Model Number: ECVC7630, UPC Number: 10653160347750. rrrrr. Model Number: ECVC6050A, UPC Number: 10653160335894; Model Number: ECVC6670, UPC Number: 10653160336624; Model Number: ECVC7660, UPC Number: 10653160347804. sssss. Model Number: ECVC7385, UPC Number: 10653160346210; Model Number: ECVC7385A, UPC Number: 10653160347392; Model Number: ECVC7700, UPC Number: 10653160348375. ttttt. Model Number: ECVC5595, UPC Number: 10653160336495. uuuuu. Model Number: ECVC6800, UPC Number: 10653160335092. vvvvv. Model Number: ECVC7785, UPC Number: 10653160349365. wwwww. Model Number: ECVC6825A, UPC Number: 10653160336631. xxxxx. Model Number: ECVC7505A, UPC Number: 10653160352853. yyyyy. Model Number: ECVC7835A, UPC Number: 10653160355359. zzzzz. Model Number: ECVC8080, UPC Number: 10653160356899. aaaaaa. Model Number: STCVC06US, UPC Number: 10653160338314. bbbbbb. Model Number: ECVC1320, UPC Number: 10653160335795. cccccc. Model Number: ECVC6255, UPC Number: 10653160336525. dddddd. Model Number: ECVC6260, UPC Number: 10653160336488. eeeeee. Model Number: ECVC5080, UPC Number: 10653160337690. ffffff. Model Number: ECVC6920, UPC Number: 10653160336716; Model Number: ECVC7000, UPC Number: 10193489196399. gggggg. Model Number: ECVC6915, UPC Number: 10653160336723; Model Number: ECVC6975, UPC Number: 10653160336679. hhhhhh. Model Number: ECVC4105, UPC Number: 10653160334835. iiiiii. Model Number: ECVC6340A, UPC Number: 10653160355038. jjjjjj. Model Number: DYNJ0429121K, UPC Number: 019532706950. kkkkkk. Model Number: ECVC7330, UPC Number: 10653160345565.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 11 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DYNJ69682; h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F; i. ANGIO-VASCULAR, Model Number: DYNJ24272C; j. ARM VASCULAR-LF, Model Number: DYNJ905290D; k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038; l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A; m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051; n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D; o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C; p. AV FIST PACK, Model Number: DYNJ83462; q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096; r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570; s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477; t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C; u. AV FISTULA VASCULAR, Model Number: DYNJ67340; v. AV GRAFT, Model Number: DYNJ903457D; w. AV GRAFT-LF, Model Number: DYNJ40077F; x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I; y. BEDSIDE PICC CDS, Model Number: CDS984642; z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339; aa. C V MAJOR PACK, Model Number: DYNJ64861A; bb. C V MINOR PACK, Model Number: DYNJ64862B; cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G; dd. CABG HEART CDS, Model Number: CDS985384C; ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F; ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A; gg. CARDIAC A B PACK-LF, Model Number: DYNJV0177AG; hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG; ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B; jj. CARDIAC CABG PACK, Model Number: DYNJ903072R; kk. CARDIAC CATH PACK, Model Number: DYNJ41195D; ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M; mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A; nn. CARDIOLOGY EP, Model Number: DYNJ59968; oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F; pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D; qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A; rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A; ss. CAROTID PACK-LF, Model Number: DYNJ57646C; tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369; uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F; vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K; ww. CATH LAB PACK, Model Number: DYNJ57735F; xx. CATH PACK, Model Number: DYNJ59830A; yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A; zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G; aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I; bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A; ddd. CV CDS, Model Number: CDS985395D; eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432; fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A; ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D; hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C; iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; kkk. DBD-AV FISTUL

Z-2300-2023
Recall number
Z-2300-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
46,124 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ44847I, UPC Number: 019532712755. b. Model Number: DYNJ82578, UPC Number: 019532719814. c. Model Number: DYNJ905291B, UPC Number: 019348995037; Model Number: DYNJ905291C, UPC Number: 019532706254. d. Model Number: DYNJ61957A, UPC Number: 019348969907. e. Model Number: DYNJ36600F, UPC Number: 088994255256. f. Model Number: DYNJV0275J, UPC Number: 019348926312; Model Number: DYNJV0275K, UPC Number: 019348926312; Model Number: DYNJV0275L, UPC Number: 019348926312; Model Number: DYNJV0275M, UPC Number: 019532701862. g. Model Number: DYNJ69682, UPC Number: 019348996892. h. Model Number: CDS840493F, UPC Number: 019348964363. i. Model Number: DYNJ24272C, UPC Number: 019348962022. j. Model Number: DYNJ905290D, UPC Number: 019532706253. k. Model Number: DYNDC3038, UPC Number: 019348949360. l. Model Number: DYNJ81636, UPC Number: 019532712918; Model Number: DYNJ81636A, UPC Number: 019532724491. m. Model Number: DYNJ83051, UPC Number: 019532724528. n. Model Number: DYNJ40728D, UPC Number: 019532734836. o. Model Number: DYNJ40728A, UPC Number: 088827704690; Model Number: DYNJ40728B, UPC Number: 019348997028; Model Number: DYNJ40728C, UPC Number: 019532703746. p. Model Number: DYNJ83462, UPC Number: 019532726814. q. Model Number: DYNJ64143B, UPC Number: 019532727958; Model Number: DYNJ905219B, UPC Number: 019348992403; Model Number: DYNJ905219C, UPC Number: 019532712693; Model Number: DYNJ905219D, UPC Number: 019532715487; Model Number: DYNJ905219F, UPC Number: 019532733532; Model Number: DYNJ906341D, UPC Number: 019532702148; Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975, UPC Number:019348996560; Model Number: DYNJ907975B, UPC Number: 019532737629; Model Number: DYNJ908096, UPC Number: 019348997407. r. Model Number: DYNJ82570, UPC Number: 019532719806. s. Model Number: DYNJ52093J, UPC Number: 019348998856; Model Number: DYNJ62218B, UPC Number: 019348996016; Model Number: DYNJ66184A, UPC Number: 019348991193; Model Number: DYNJ66184B, UPC Number: 019532703433; Model Number: DYNJ67178A, UPC Number: 019532702787; Model Number: DYNJ69443A, UPC Number: 019532702654; Model Number: DYNJ69443B, UPC Number: 019532708906; Model Number: DYNJ69443D, UPC Number: 019532727023; Model Number: DYNJ69489A, UPC Number: 019532722704; Model Number: DYNJ81033, UPC Number: 019532708298; Model Number: DYNJ81605, UPC Number: 019532712388; Model Number: DYNJ82477, UPC Number: 019532719722. t. Model Number: DYNJ64499B, UPC Number: 019348996109; Model Number: DYNJ64499, UPC Number: 019532722644; Model Number: DYNJ69167A, UPC Number: 019532708351; Model Number: DYNJ69167C, UPC Number: 019532734312. u. Model Number: DYNJ67340, UPC Number: 019348990107. v. Model Number: DYNJ903457D, UPC Number: 019348967091. w. Model Number: DYNJ40077F, UPC Number: 019532717581. x. Model Number: CDS983147F, UPC Number: 019348963379; Model Number: CDS983147I, UPC Number: 019532707551. y. Model Number: CDS984642, UPC Number: 088438988292. z. Model Number: DYNJ907339, UPC Number: 019348939732. aa. Model Number: DYNJ64861A, UPC Number: 019532705363. bb. Model Number: DYNJ64862B, UPC Number: 019532705370. cc. Model Number: DYNJ906878A, UPC Number: 019348939130; Model Number: DYNJ9372030F, UPC Number: 019348966807; Model Number: DYNJ9372030G, UPC Number: 019532702543. dd. Model Number: CDS985384C, UPC Number: 088994296218. ee. Model Number: DYNJ0408782AA, UPC Number: 019532711581; Model Number: DYNJ53827, UPC Number: 088994244401; Model Number: DYNJ59036B, UPC Number: 019348967227; Model Number: DYNJ59036C, UPC Number: 019348988162; Model Number: DYNJ59036D, UPC Number: 019532700347; Model Number: DYNJ59036F, UPC Number: 019532727293. ff. Model Number: DYNJ68389, UPC Number: 019348944114; Model Number: DYNJ68389A, UPC Number: 019348991219. gg. Model Number: DYNJV0177AG, UPC Number: 019532711235. hh. Model Number: DYNJV0177AG, UPC Number: 019532711235. ii. Model Number: DYNJ908121A, UPC Number: 019532700057; Model Number: DYNJ908121B, UPC Number: 019532709571. jj. Model Number: DYNJ903072R, UPC Number: 019348983405. kk. Model Number: DYNJ41195D, UPC Number: 019348931425. ll. Model Number: DYNJ0429185K, UPC Number: 019348956435; Model Number: DYNJ0429185M, UPC Number: 019532737135. mm. Model Number: DYNJ66254A, UPC Number: 019348981897. nn. Model Number: DYNJ59968, UPC Number: 088827779132. oo. Model Number: DYNJ905516C, UPC Number: 019348996712; Model Number: DYNJ905516D, UPC Number: 019532714783; Model Number: DYNJ905516F, UPC Number: 019532724757. pp. Model Number: DYNJ906351B, UPC Number: 019348981671; Model Number: DYNJ906351D, UPC Number: 019532716157. qq. Model Number: DYNJ905640A, UPC Number: 019532703918. rr. Model Number: DYNJ0810062AI, UPC Number: 019348956435; Model Number: DYNJ0810062AJ, UPC Number: 019532732546; Model Number: DYNJ39488G, UPC Number: 019348938377; Model Number: DYNJ66190A, UPC Number: 019348991300; Model Number: DYNJ66190B, UPC Number: 019532703432; Model Number: DYNJ66190C, UPC Number: 019532734200; Model Number: DYNJ80346A, UPC Number: 019532716625. ss. Model Number: DYNJ57646C, UPC Number: 019532728713. tt. Model Number: DYNJ81369, UPC Number: 019532711530. uu. Model Number: DYNJ44927F, UPC Number: 019348976680. vv. Model Number: CDS984764F, UPC Number: 088994296945; Model Number: DYNJ901745K, UPC Number: 019348948223. ww. Model Number: DYNJ57735F, UPC Number: 019348962970. xx. Model Number: DYNJ59830A, UPC Number: 019348957023. yy. Model Number: DYNJ62379A, UPC Number: 019532719663. zz. Model Number: DYNJC9258G, UPC Number: 019532724550. aaa. Model Number: CDS983202F, UPC Number: 019348933525; Model Number: CDS983202G, UPC Number: 019348949077; Model Number: CDS983202I, UPC Number: 019532716467. bbb. Model Number: DYNJ906108A, UPC Number: 019348944363; Model Number: DYNJ906108B, UPC Number: 019532704117; Model Number: DYNJ906108C, UPC Number: 019532711827. ccc. Model Number: DYNJ65710A, UPC Number: 019348993865. ddd. Model Number: CDS985395D, UPC Number: 019348985971. eee. Model Number: DYNJ83432, UPC Number: 019532726653. fff. Model Number: DYNJ64506A, UPC Number: 019348997106. ggg. Model Number: DYNJ46359C, UPC Number: 088994253711; Model Number: DYNJ46359D, UPC Number: 019348996137. hhh. Model Number: DYNJ905291C, UPC Number: 019532706254. iii. Model Number: CDS840493F, UPC Number: 019348964363. jjj. Model Number: CDS840493F, UPC Number: 019348964363. kkk. Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975A, UPC Number: 019532715507. lll. Model Number: DYNJ69443C, UPC Number: 019532712973. mmm. Model Number: DYNJ57646B, UPC Number: 019348982850. nnn. Model Number: DYNJ64964B, UPC Number: 019532707581. ooo. Model Number: DYNJ59028A, UPC Number: 019348973659. ppp. Model Number: DYNJ907552A, UPC Number: 019532716605. qqq. Model Number: DYNJ56904, UPC Number: 088994269345. rrr. Model Number: DYNJ63209, UPC Number: 019348972788. sss. Model Number: DYNJ67487B, UPC Number: 019532716614. ttt. Model Number: DYNJ905495F, UPC Number: 019348992493. uuu. Model Number: DYKMBNDL22B, UPC Number: 019532705026. vvv. Model Number: DYNJ905884A, UPC Number: 019348979544. www. Model Number: DYNJ81610, UPC Number: 019532712394. xxx. Model Number: DYNJ54286A, UPC Number: 088994276549. yyy. Model Number: CDS984241M, UPC Number: 019532716563. zzz. Model Number: DYNJ23697N, UPC Number: 019348949845. aaaa. Model Number: DYNJ55836B, UPC Number: 019348995117. bbbb. Model Number: DYNJ63341C, UPC Number: 019532708612. cccc. Model Number: DYNJ48365, UPC Number: 088827759459. dddd. Model Number: DYNJ69422, UPC Number: 019348993754. eeee. Model Number: DYNJ905744C, UPC Number: 019532716231. ffff. Model Number: CDS984764G, UPC Number: 019348945029. gggg. Model Number: DYNJ81642, UPC Number: 019532712966. hhhh. Model Number: DYNJ68404A, UPC Number: 019348991392. iiii. Model Number: DYNJ65048, UPC Number: 019348924286. jjjj. Model Number: DYNJ43085A, UPC Number: 019348960034. kkkk. Model Number: DYNJ64261A, UPC Number: 019348932556. llll. Model Number: DYNJ42976, UPC Number: 088827701914. mmmm. Model Number: DYNJ907914, UPC Number: 019348994367; Model Number: DYNJ907914A, UPC Number: 019532714952; Model Number: DYNJ907914B, UPC Number: 019532718060; Model Number: DYNJ907914C, UPC Number: 019532732943. nnnn. Model Number: DYNJ57595A, UPC Number: 019348962215. oooo. Model Number: DYNJ0037939B, UPC Number: 019532703127. pppp. Model Number: DYNJ52024, UPC Number: 088994223335. qqqq. Model Number: DYNJ51968D, UPC Number: 019348967831. rrrr. Model Number: DYNJ56235, UPC Number: 088994262155. ssss. Model Number: DYNJ61247, UPC Number: 019348955170. tttt. Model Number: DYNJ907552A, UPC Number: 019532716605. uuuu. Model Number: DYNJ67517A, UPC Number: 019348946219. vvvv. Model Number: PHS41732B, UPC Number: 019348978481. wwww. Model Number: DYNJ55669C, UPC Number: 019348944785; Model Number: DYNJ55669D, UPC Number: 019532701301. xxxx. Model Number: DYNJ57449C, UPC Number: 019348947184; Model Number: DYNJ57449D, UPC Number: 019348987229; Model Number: DYNJ57449F, UPC Number: 019348993920; Model Number: DYNJ57449G, UPC Number: 019532706488. yyyy. Model Number: DYNJ49931I, UPC Number: 019348993921. zzzz. Model Number: DYNJ54803B, UPC Number: 019348963378; Model Number: DYNJ54803C, UPC Number: 019348920261.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 12 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K; i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067; j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F; k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D; l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F; m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C; n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489; o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A; p. ENDOVENOUS PACK, Model Number: DYNJ83606; q. ENT FREE FLAP, Model Number: SYNJ910018B; r. EP ANGIO PACK, Model Number: DYNJ25749S; s. EP DRAPE PACK-LF, Model Number: DYNJ47645C; t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F; u. EP PACER PACK, Model Number: DYNJ67770; v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B; w. EP PROCEDURE PACK, Model Number: DYNJ67771; x. EP TRAY, Model Number: DYNJ31928D; y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F; z. FEM POP PACK, Model Number: DYNJ67487C; aa. FISTULA PACK, Model Number: DYNJ82711; bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A; cc. GENERAL HEART, Model Number: DYNJ907915; dd. GROTH LASER VEIN CDS, Model Number: CDS984193O; ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K; ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198; gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F; hh. HEART A PACK, Model Number: DYNJ0541930N; ii. HEART FAILURE PACK, Model Number: DYNJ64877B; jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C; kk. HEART PACK, Model Number: DYNJ48424A; ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J; mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B; nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A; oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F; pp. HMT VEIN PACK, Model Number: DYNJ38756B; qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B; rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C; ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A; tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B; uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A; vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A; ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076; xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C; yy. KIT LB OPEN HEART, Model Number: CDS840487G; zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B; aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A; bbb. KIT OPEN HEART, Model Number: DYNJ906113; ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B; ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23; eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A; fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; ggg. KIT VASCULAR RF, Model Number: DYNJ906960A; hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F; iii. LASER ABLATION, Model Number: DYNJ48962B; jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725; kkk. LASER PACK, Model Number: DYNJ65294; lll. LB OPEN HEART BOX, Model Number: DYNJ905859B; mmm. LEE VEIN PACK, Model Number: DYNJ54906B; nnn. LEG VASCULAR SUPPLY -LF, Model Number: D

Z-2301-2023
Recall number
Z-2301-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
41,123 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ0842825D, UPC Number: 019532728861. b. Model Number: DYNJ49933I, UPC Number: 019348947168; Model Number: DYNJ49933J, UPC Number: 019532706561. c. Model Number: DYNJ44808G, UPC Number: 019348987585. d. Model Number: DYNJ51304B, UPC Number: 088994236595; Model Number: DYNJ51304C, UPC Number: 019348946098. e. Model Number: DYNJ0678934D, UPC Number: 019348956435; Model Number: DYNJ0678934F, UPC Number: 019348956435; Model Number: DYNJ82567, UPC Number: 019532719803. f. Model Number: DYNJ0676055N, UPC Number: 019348956435. g. Model Number: DYNJ63343A, UPC Number: 019348929199; Model Number: DYNJ63343B, UPC Number: 019348947045; Model Number: DYNJ63343D, UPC Number: 019348996760; Model Number: DYNJ63343F, UPC Number: 019532708613; Model Number: DYNJ908880, UPC Number: 019532720343. h. Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; Model Number: CDS983394K, UPC Number: 019532729258. i. Model Number: DYNJVB91067, UPC Number: 019348980153. j. Model Number: DYNJ906354D, UPC Number: 019348998657; Model Number: DYNJ906354F, UPC Number: 019532702150. k. Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; Model Number: DYNJ905726D, UPC Number: 019532716151. l. Model Number: DYNJ42831F, UPC Number: 019348988032. m. Model Number: DYNJ67750, UPC Number: 019348942917, Model Number: DYNJ67750A, UPC Number: 019348983224, Model Number: DYNJ67750B, UPC Number: 019348991204, Model Number: DYNJ67750C, UPC Number: 019532734136. n. Model Number: DYNJ80489, UPC Number: 019532704584. o. Model Number: DYNJ48456C, UPC Number: 019532701586; Model Number: DYNJ69108A, UPC Number: 019532702571. p. Model Number: DYNJ83606, UPC Number: 019532728485. q. Model Number: SYNJ910018B, UPC Number: 019532700730. r. Model Number: DYNJ25749S, UPC Number: 019532705970. s. Model Number: DYNJ47645C, UPC Number: 019532735517. t. Model Number: DYNJ59392D, UPC Number: 019532705357; Model Number: DYNJ59392F, UPC Number: 019532713598. u. Model Number: DYNJ67770, UPC Number: 019348943071. v. Model Number: DYNJ23456K, UPC Number: 019348996776; Model Number: DYNJ68019, UPC Number: 019348946784; Model Number: DYNJ81716, UPC Number: 019532713806; Model Number: DYNJ81716A, UPC Number: 019532720385; Model Number: DYNJ81716B, UPC Number: 019532727726. w. Model Number: DYNJ67771, UPC Number: 019348943072. x. Model Number: DYNJ31928D, UPC Number: 019532733528. y. Model Number: DYNJ53480F, UPC Number: 019348942488. z. Model Number: DYNJ67487C, UPC Number: 019532726074. aa. Model Number: DYNJ82711, UPC Number: 019532720362. bb. Model Number: DYNJ69943A, UPC Number: 019532728463. cc. Model Number: DYNJ907915, UPC Number: 019348994368. dd. Model Number: CDS984193O, UPC Number: 019348937708. ee. Model Number: DYNJ46590I, UPC Number: 019348975763; Model Number: DYNJ46590J, UPC Number: 019348947369; Model Number: DYNJ46590K, UPC Number: 019532709400. ff. Model Number: DYNJ68198, UPC Number: 019348949917. gg. Model Number: DYNJ51925F, UPC Number: 019532715339. hh. Model Number: DYNJ0541930N, UPC Number: 019348971892. ii. Model Number: DYNJ64877B, UPC Number: 019348941589. jj. Model Number: DYNJ55528A, UPC Number: 088994297663; Model Number: DYNJ55528B, UPC Number: 019532704649; Model Number: DYNJ55528C, UPC Number: 019532724820. kk. Model Number: DYNJ48424A, UPC Number: 088827792129. ll. Model Number: DYNJ58365C, UPC Number: 019348945985; Model Number: DYNJ58365F, UPC Number: 019348982057; Model Number: DYNJ58365G, UPC Number: 019348988393; Model Number: DYNJ58365J, UPC Number: 019532701909. mm. Model Number: DYNJ62851B, UPC Number: 019348927121. nn. Model Number: DYNJ62850A, UPC Number: 019348978423. oo. Model Number: DYNJ905495D, UPC Number: 019348983924; Model Number: DYNJ905495F, UPC Number: 019348992493. pp. Model Number: DYNJ38756B, UPC Number: 019348956435. qq. Model Number: DYNJ907571A, UPC Number: 019348992612; Model Number: DYNJ907571B, UPC Number: 019532726241. rr. Model Number: DYNJ40215C, UPC Number: 019532717650. ss. Model Number: DYNJ52756A, UPC Number: 019348941383. tt. Model Number: DYNJ47138B, UPC Number: 088994227421. uu. Model Number: DYNJ82858A, UPC Number: 019532724489. vv. Model Number: DYNJ82859A, UPC Number: 019532724490. ww. Model Number: DYNJ66076, UPC Number: 019348931923. xx. Model Number: DYKMBNDL22C, UPC Number: 019532724096. yy. Model Number: CDS840487G, UPC Number: 019348967442. zz. Model Number: DYNJ907262, UPC Number: 019348938515, Model Number: DYNJ907262B, UPC Number: 019532711641. aaa. Model Number: DYKMBNDL148A, UPC Number: 019532724129. bbb. Model Number: DYNJ906113, UPC Number: 019348965872. ccc. Model Number: DYNJ906086B, UPC Number: 019532704635. ddd. Model Number: DYKMBNDL23, UPC Number: 019348947918. eee. Model Number: DYNJ906098, UPC Number: 019348963877; Model Number: DYNJ906098A, UPC Number: 019348920945. fff. Model Number: DYKMBNDL118A, UPC Number: 019532724067. ggg. Model Number: DYNJ906960A, UPC Number: 019532700259. hhh. Model Number: DYNJ56283C, UPC Number: 019348926872; Model Number: DYNJ56283D, UPC Number: 019532709387; Model Number: DYNJ56283F, UPC Number: 019532721185. iii. Model Number: DYNJ48962B, UPC Number: 088994212967. jjj. Model Number: DYNJ38995C, UPC Number: 019348971314, Model Number: DYNJ67725, UPC Number: 019348942584. kkk. Model Number: DYNJ65294, UPC Number: 019348926426. lll. Model Number: DYNJ905859B, UPC Number: 019348941786. mmm. Model Number: DYNJ54906B, UPC Number: 019348928963. nnn. Model Number: DYNJ905626B, UPC Number: 019348963423. ooo. Model Number: DYNJ81407, UPC Number: 019532711766. ppp. Model Number: DYNJ41100C, UPC Number: 019348989982. qqq. Model Number: DYNJ0678934G, UPC Number: 019348956435. rrr. Model Number: DYNJ902168C, UPC Number: 019348945421. sss. Model Number: DYNJ908687, UPC Number: 019532714092. ttt. Model Number: DYNJ61373, UPC Number: 019348957669. uuu. Model Number: DYNJ901062D, UPC Number: 019348921181; Model Number: DYNJ905641, UPC Number: 019348952766; Model Number: DYNJ905641A, UPC Number: 019532703927; Model Number: DYNJ906371B, UPC Number: 019348981669; Model Number: DYNJ906371C, UPC Number: 019532702146; Model Number: DYNJ906951, UPC Number: 019348929999; Model Number: DYNJ906951A, UPC Number: 019532712835; Model Number: DYNJ908390, UPC Number: 019532708832. vvv. Model Number: CDS840368M, UPC Number: 019348949162; Model Number: CDS840368N, UPC Number: 019532702036; Model Number: CDS840368P, UPC Number: 019532732286. www. Model Number: DYNJ45515D, UPC Number: 019348936735; Model Number: DYNJ81610A, UPC Number: 019532731504. xxx. Model Number: DYNJC9307F, UPC Number: 019348926312; Model Number: DYNJC9307G, UPC Number: 019532703329. yyy. Model Number: DYNJ82988, UPC Number: 019532722220; Model Number: DYNJ82988A, UPC Number: 019532729331. zzz. Model Number: DYNJ82987, UPC Number: 019532722211. aaaa. Model Number: DYNJ0622403O, UPC Number: 088994221921. bbbb. Model Number: DYNJ66916A, UPC Number: 019348999322. cccc. Model Number: DYNJ903705I, UPC Number: 019348997955. dddd. Model Number: DYNJ903706K, UPC Number: 019348999413. eeee. Model Number: DYNJ53433G, UPC Number: 019532704243; Model Number: DYNJ53433I, UPC Number: 019532707449; Model Number: DYNJ53433J, UPC Number: 019532722292. ffff. Model Number: DYNJ44122B, UPC Number: 019348923136. gggg.Model Number: DYNJ904171D, UPC Number: 019348945094; Model Number: DYNJ904171F, UPC Number: 019348943924; Model Number: DYNJ907063A, UPC Number: 019348983381; Model Number: DYNJ908391, UPC Number: 019532708831. hhhh. Model Number: DYNJ60713, UPC Number: 019348952003; Model Number: DYNJ60713A, UPC Number: 019532701206; Model Number: DYNJ68616, UPC Number: 019348983858; Model Number: DYNJ69036, UPC Number: 019348988394. iiii. Model Number: DYNJ0349727D, UPC Number: 019532700015. jjjj. Model Number: DYNJ31148I, UPC Number: 019348956435. kkkk. Model Number: DYNJ61584A, UPC Number: 019348981281. llll. Model Number: CDS984231T, UPC Number: 019348962640. mmmm. Model Number: CDS984241L, UPC Number: 019348996186; Model Number: CDS984241M, UPC Number: 019532716563. nnnn. Model Number: DYNJ63892A, UPC Number: 019532717651. oooo. Model Number: DYNJ62735, UPC Number: 019348968528. pppp. Model Number: 00-401185Q, UPC Number: 019348948908. qqqq. Model Number: DYNJ52056C, UPC Number: 019348936944; Model Number: DYNJ52056D, UPC Number: 019532709613. rrrr. Model Number: DYNJ904261B, UPC Number: 019348947953; Model Number: DYNJ905311D, UPC Number: 019348926126; Model Number: DYNJ906760C, UPC Number: 019348999431; Model Number: DYNJ906760D, UPC Number: 019532724695; Model Number: DYNJ9718008AS, UPC Number: 019348926312; Model Number: CDS981161AC, UPC Number: 019532727643. ssss. Model Number: CDS985105N, UPC Number: 019348990229; Model Number: CDS985105O, UPC Number: 019532703624. tttt. Model Number: DYNJ0450131AI, UPC Number: 019348946612. uuuu. Model Number: DYNJ20888K, UPC Number: 019532736012. vvvv. Model Number: DYNJ23533B, UPC Number: 019348956435; Model Number: DYNJ23533D, UPC Number: 019348947065. wwww. Model Number: CDS983849D, UPC Number: 019348927823, Model Number: CDS983849F, UPC Number: 019532722831. xxxx. Model Number: DYNJ55836A, UPC Number: 019348955285. yyyy. Model Number: DYNJ0149567B, UPC Number: 088827773796; Model Number: DYNJ0149567C, UPC Number: 019532723552. zzzz. Model Number: CDS983513F, UPC Number: 019348984372; Model Number: CDS984355F, UPC Number: 088827777034; Model Number: CDS984355G, UPC Number: 019348948463; Model Number: DYNJ905311F, UPC Number: 019348990224; Model Number: DYNJ905311I, UPC Number: 019532714621; Model Number: DYNJ907607A, UPC Number: 019348987340; Model Number: DYNJ907607B, UPC Number: 019532717419.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 13 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N; g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W; h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P; i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A; j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B; k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F; l. OPEN VASCULAR UE, Model Number: DYNJ907858A; m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451; n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C; o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295; p. PACER SET UP PACK, Model Number: DYNJ63069A; q. PACK AV FISTULA, Model Number: DYNJ60115B; r. PACK MINOR VASCULAR, Model Number: NG340C; s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D; t. PEDI EP PACK, Model Number: DYNJ54750G; u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G; v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I; w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A; x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I; y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C; z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566; aa. PERMA CATH PACK, Model Number: DYNJ62007B; bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010; cc. PK OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A; dd. PK, OPEN HEART, Model Number: DYNJ61645A; ee. PK, VASCULAR, Model Number: DYNJ54305; ff. PORT PACK, Model Number: DYNJ68990A; gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A; hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492; ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618; jj. PRX AV FISTULA PACK, Model Number: DYNJ66184; kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C; ll. PUMP PACK, Model Number: DYNJ64601B; mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B; nn. PV CAROTID PACK, Model Number: DYNJ63341D; oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L; pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K; qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A; rr. RFD-CAROTID, Model Number: DYNJ54287B; ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A; tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B; uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B; vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U; ww. RIGHT HEART TRAY, Model Number: DYNJ40379D; xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C; yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L; zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B; aaa. SCA VEIN PACK, Model Number: DYNJ63817; bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F; ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521; ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418; eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314; fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I; ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C; hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918; iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563; jjj. STROKE KIT, Model Number: DYNJ80506; kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A; lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B; mmm. SVMMC CAROTID PACK, Model Number: DYNJ43861F; nnn. SVMMC AV

Z-2302-2023
Recall number
Z-2302-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
43,149 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CDS840451L, UPC Number: 019532715163. b. Model Number: DYNJ908179, UPC Number: 019348999908; Model Number: DYNJ908179A, UPC Number: 019532722257. c. Model Number: DYNJ43741B, UPC Number: 088994282107; Model Number: DYNJ66216, UPC Number: 019348932622; Model Number: DYNJ66216A, UPC Number: 019348991365; Model Number: DYNJ66216B, UPC Number: 019532703430; Model Number: DYNJ66216C, UPC Number: 019532734492. d. Model Number: DYNJ53984G, UPC Number: 019532728288. e. Model Number: DYNJ0283397T, UPC Number: 019348956435; Model Number: DYNJ0283397U, UPC Number: 019532708366; Model Number: DYNJ53984F, UPC Number: 019348946948; Model Number: DYNJ53984G, UPC Number: 019532728288. f. Model Number: DYNJ0371669N, UPC Number: 019348923039. g. Model Number: DYNJ22232W, UPC Number: 019532732560. h. Model Number: DYNJ901075O, UPC Number: 019532705268; Model Number: DYNJ901075P, UPC Number: 019532725355. i. Model Number: DYNJ901821A, UPC Number: 019532731932. j. Model Number: DYNJ63153B, UPC Number: 019348984168. k. Model Number: DYNJ63099F, UPC Number: 019532715003. l. Model Number: DYNJ907858A, UPC Number: 019532713135. m. Model Number: DYNJ62451, UPC Number: 019348965833. n. Model Number: DYNJ906019C, UPC Number: 019348941128. o. Model Number: DYNJ81295, UPC Number: 019532710670. p. Model Number: DYNJ63069A, UPC Number: 019348942361. q. Model Number: DYNJ60115B, UPC Number: 019532711880. r. Model Number: NG340C, UPC Number: 019532730520. s. Model Number: DYNJ905692D, UPC Number: 019532720229. t. Model Number: DYNJ54750G, UPC Number: 019532702135. u. Model Number: DYNJ35578G, UPC Number: 019348980860. v. Model Number: CDS840487I, UPC Number: 019348944534. w. Model Number: PAIN1423A, UPC Number: 019348920182. x. Model Number: DYNJ44562F, UPC Number: 019348973734; Model Number: DYNJ901068D, UPC Number: 019348921186; Model Number: DYNJ901068F, UPC Number: 019348994461; Model Number: DYNJ901068I, UPC Number: 019532723251. y. Model Number: SYNJ910022A, UPC Number: 019348937421; Model Number: SYNJ910022B, UPC Number: 019532700726; Model Number: SYNJ910022C, UPC Number: 019532735820. z. Model Number: DYNJ82566, UPC Number: 019532719802. aa. Model Number: DYNJ62007B, UPC Number: 019532716196. bb. Model Number: PICCNC0010, UPC Number: 019532723117. cc. Model Number: DYNJ45074C, UPC Number: 019348922267; Model Number: DYNJ61645A, UPC Number: 019348978134. dd. Model Number: DYNJ61645A, UPC Number: 019348978134. ee. Model Number: DYNJ54305, UPC Number: 088994247639. ff. Model Number: DYNJ68990A, UPC Number: 019348998136. gg. Model Number: DYNJ65775A, UPC Number: 019532714022. hh. Model Number: DYNJ68492, UPC Number: 019348982724. ii. Model Number: DYNJ43922, UPC Number: 088827707466; Model Number: DYNJ68968A, UPC Number: 019532720684; Model Number: DYNJ81618, UPC Number: 019532712460. jj. Model Number: DYNJ66184, UPC Number: 019348932118. kk. Model Number: DYNJ907554A, UPC Number: 019532702463; Model Number: DYNJ907554C, UPC Number: 019532718383. ll. Model Number: DYNJ64601B, UPC Number: 019532728473. mm. Model Number: DYNJ62197A, UPC Number: 019348999409; Model Number: DYNJ62197B, UPC Number: 019532716724. nn. Model Number: DYNJ63341D, UPC Number: 019532727362. oo. Model Number: DYNJ46549K, UPC Number: 019532700829; Model Number: DYNJ46549L, UPC Number: 019532729066. pp. Model Number: DYNJ47660K, UPC Number: 019348987573. qq. Model Number: DYNJ61894A, UPC Number: 019348973096. rr. Model Number: DYNJ54287B, UPC Number: 019532716711. ss. Model Number: DYNJ54265A, UPC Number: 019532715233. tt. Model Number: DYNJ54285B, UPC Number: 019532714203. uu. Model Number: DYNJ54286B, UPC Number: 019532714578. vv. Model Number: DYNJ0565558U, UPC Number: 019348982703. ww. Model Number: DYNJ40379D, UPC Number: 019348925761. xx. Model Number: DYNJ55757C, UPC Number: 019532711653. yy. Model Number: DYNJ33544J, UPC Number: 019348956435; Model Number: DYNJ33544K, UPC Number: 019348956435; Model Number: DYNJ33544L, UPC Number: 019532727931. zz. Model Number: DYNJ908074B, UPC Number: 019532717268. aaa. Model Number: DYNJ63817, UPC Number: 019348976395. bbb. Model Number: DYNJ906102D, UPC Number: 019348982234; Model Number: DYNJ906102F, UPC Number: 019532702826. ccc. Model Number: DYNJ83521, UPC Number: 019532727464. ddd. Model Number: DYNJ65418, UPC Number: 019348927371. eee. Model Number: DYNJ82314, UPC Number: 019532718421. fff. Model Number: DYNJ49833I, UPC Number: 019348988536. ggg. Model Number: DYNJ20031C, UPC Number: 088438965007. hhh. Model Number: DYNJ80918, UPC Number: 019532708492. iii. Model Number: DYNJ908563, UPC Number: 019532708642. jjj. Model Number: DYNJ80506, UPC Number: 019532704917. kkk. Model Number: DYNJ69009, UPC Number: 019348987684; Model Number: DYNJ69009A, UPC Number: 019532707556. lll. Model Number: DYNJ54014B, UPC Number: 088994276032. mmm. Model Number: DYNJ43861F, UPC Number: 019348998164. nnn. Model Number: DYNJ48153F, UPC Number: 019348998969. ooo. Model Number: DYNJ43777J, UPC Number: 019348999018. ppp. Model Number: DYNJ57539B, UPC Number: 019348930066; Model Number: DYNJ907561, UPC Number: 019348982123; Model Number: DYNJ907561A, UPC Number: 019532702884; Model Number: DYNJ908646, UPC Number: 019532712395; Model Number: DYNJ908646A, UPC Number: 019532731496. qqq. Model Number: DYNJ904401C, UPC Number: 019348934891; Model Number: DYNJ905859, UPC Number: 019348954552. rrr. Model Number: DYNJ52766A, UPC Number: 019348929236; Model Number: DYNJ62915B, UPC Number: 019348936535; Model Number: DYNJ63340A, UPC Number: 019532727358; Model Number: DYNJ66769, UPC Number: 019348938052; Model Number: DYNJ68933, UPC Number: 019348986037; Model Number: DYNJ81095, UPC Number: 019532708412; Model Number: DYNJ82863A, UPC Number: 019532724504. sss. Model Number: DYNJ66152A, UPC Number: 019348982021; Model Number: DYNJ66152B, UPC Number: 019532709042. ttt. Model Number: DYNJ906391D, UPC Number: 019532702147. uuu. Model Number: DYNJ903919J, UPC Number: 019532704590; Model Number: DYNJ903919K, UPC Number: 019532721878; Model Number: DYNJ903919L, UPC Number: 019532726705. vvv. Model Number: DYNJ64449, UPC Number: 019348920157. www. Model Number: TVS4000L, UPC Number: 019532722354. xxx. Model Number: DYNJ55427B, UPC Number: 019348978611; Model Number: DYNJ55427C, UPC Number: 019532712656; Model Number: DYNJ55427D, UPC Number: 019532727261. yyy. Model Number: DYNJ907201, UPC Number: 019348935833; Model Number: DYNJ907201B, UPC Number: 019348994665. zzz. Model Number: DYNJ69622, UPC Number: 019348995958. aaaa. Model Number: DYNJ69302, UPC Number: 019348992627. bbbb. Model Number: DYNJ81705, UPC Number: 019532713557. cccc. Model Number: DYNJ906882A, UPC Number: 019348939123. dddd. Model Number: DYNJ58915, UPC Number: 088994290385; Model Number: DYNJ65842, UPC Number: 019348929631. eeee. Model Number: CDS985355C, UPC Number: 019348931018; Model Number: CDS985355D, UPC Number: 019348944277; Model Number: CDS985355F, UPC Number: 019532724262; Model Number: DYNJ900293J, UPC Number: 019348991514; Model Number: DYNJ902554I, UPC Number: 019348921874; Model Number: DYNJ902704P, UPC Number: 019348986337; Model Number: DYNJ904397D, UPC Number: 019348970120; Model Number: DYNJ904397F, UPC Number: 019348997971; Model Number: DYNJ906021B, UPC Number: 019348941129; Model Number: DYNJ906883A, UPC Number: 019348939820; Model Number: DYNJ909007, UPC Number: 019532724004; Model Number: DYNJ909091, UPC Number: 019532726860. ffff. Model Number: DYNJ59796C, UPC Number: 019348990421. gggg. Model Number: DYNJ81022, UPC Number: 019532708278. hhhh. Model Number: DYNDA2526, UPC Number: 019348919179. iiii. Model Number: DYNJ52606C, UPC Number: 019348973825; Model Number: DYNJ52606D, UPC Number: 019348981280; Model Number: DYNJ52606F, UPC Number: 019348934329. jjjj. Model Number: DYNJ905285C, UPC Number: 019348994725. kkkk. Model Number: DYNJ44420C, UPC Number: 019348959033; Model Number: DYNJ82698, UPC Number: 019532720300. llll. Model Number: DYNJ82109, UPC Number: 019532717124. mmmm. Model Number: DYNJ902259B, UPC Number: 019348991971. nnnn. Model Number: DYNJ904984, UPC Number: 088994278935, Model Number: DYNJ904984B, UPC Number: 019348981293. oooo. Model Number: CDS983040J, UPC Number: 019348924185; Model Number: CDS983040K, UPC Number: 019348984199; Model Number: CDS983136F, UPC Number: 019348921152; Model Number: CDS983136G, UPC Number: 019532714892. pppp. Model Number: CDS982751K, UPC Number: 019348982501. qqqq. Model Number: CDS983390G, UPC Number: 019348982050; Model Number: CDS983390I, UPC Number: 019532710364; Model Number: CDS983390J, UPC Number: 019532720540. rrrr. Model Number: DYNJ902261F, UPC Number: 019348927536; Model Number: DYNJ902261G, UPC Number: 019348991972; Model Number: DYNJ905859, UPC Number: 019348954552. ssss. Model Number: DYNJ37445I, UPC Number: 019348941739. tttt. Model Number: DYNJ81023, UPC Number: 019532708279. uuuu. Model Number: DYNJ53433F, UPC Number: 019348932867. vvvv. Model Number: DYNJ81200, UPC Number: 019532709169; Model Number: DYNJ81200A, UPC Number: 019532722471. wwww. Model Number: DYNJ81642A, UPC Number: 019532726638. xxxx. Model Number: DYNJVB91050A, UPC Number: 019532717172. yyyy. Model Number: DYNJ46100G, UPC Number: 019348926846; Model Number: DYNJ46100I, UPC Number: 019348985640. zzzz. Model Number: DYNJ0103507AF, UPC Number: 019348956435; Model Number: DYNJ0103507AI, UPC Number: 019348956435; Model Number: DYNJ0103507AJ, UPC Number: 019532730242.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 14 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146; b. VASCULAR PACK CHRG, Model Number: DYNJ59778A, DYNJ59778B; c. VASCULAR PACK GWV, Model Number: DYNJ59245; DYNJ59245A; d. VASCULAR PACK MH-LF, Model Number: DYNJ39866B, DYNJ39866C; e. VASCULAR PACK SHD, Model Number: DYNJ68404; f. VASCULAR PACK-LF, Model Number: DYNJ0250564O, DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O; g. VASCULAR STENT INOVA, Model Number: DYNJ906440A; h. VASCULAR TRAY, Model Number: DYNJ56858; i. VASCULAR/OR ANGIO, Model Number: DYNJ905079F; j. VASCULAR-LF, Model Number: DYNJ900714B, DYNJ900714C; k. VEIN ABLATION EXCISION ASC, Model Number: DYNJ52586B; l. VEIN ABLATION & EXCISION ASC, Model Number: DYNJ52586, DYNJ52586A, DYNJ52586B; m. VEIN ABLATION KIT, Model Number: DYNJ69272A; n. VEIN ABLATION PACK, Model Number: DYNJ62889; o. VEIN ABLATION TRAY W/CHLOR, Model Number: DYNJ64396; p. VEIN AND LASER PACK, Model Number: DYNJ49874; q. VEIN CENTER PACK, Model Number: DYNJ52123; r. VEIN CLINIC, Model Number: DYNJ68667; s. VEIN CLOSURE PACK, Model Number: DYNJ35586G, DYNJ39408F, DYNJ65189B; t. VEIN CLOSURE TRAY, Model Number: DYNJ44737B; u. VEIN KIT, Model Number: DYNJ57047; v. VEIN LIGATION, Model Number: DYNJ64190; w. VEIN OHH, Model Number: DYNJ65560A; x. VEIN PACK, Model Number: DYNJ21949J, DYNJ39005B, DYNJ39889, DYNJ48493, DYNJ48907F, DYNJ50785, DYNJ52098, DYNJ52993A, DYNJ53160, DYNJ53160A, DYNJ54153B, DYNJ55268, DYNJ55462A, DYNJ55514A, DYNJ55849A, DYNJ56624, DYNJ56724A, DYNJ56724B, DYNJ57512, DYNJ57835, DYNJ57917, DYNJ58063, DYNJ58609, DYNJ59151F, DYNJ59662B, DYNJ59662D, DYNJ59677A, DYNJ59681A, DYNJ61540C, DYNJ63823, DYNJ64282, DYNJ64471A, DYNJ65579, DYNJ66154, DYNJ66743A, DYNJ68749, DYNJ69091, DYNJ80199A, DYNJ80199B, DYNJ80868, DYNJ83147; y. VEIN PACK II, Model Number: DYNJ66427; z. VEIN PACK-LF, Model Number: DYNJ66271A, DYNJ66271C; aa. VEIN PROCEDURE, Model Number: DYNJ65342A; bb. VEIN PROCEDURE PACK, Model Number: DYNJ38264D, DYNJ62038A, DYNJ64909; cc. VEIN SPECIALISTS PACK, Model Number: DYNJ53616A; dd. VEIN TRAY, Model Number: DYNJ57003, DYNJ62829A; ee. VENOUS ABLATION, Model Number: DYNJ50227C; ff. VENOUS ACCESS ACCESSORY PACK, Model Number: DYNJ61010A; gg. VENOUS ACCESS PACK, Model Number: DYNJ44421D; hh. VIRC STROKE PACK, Model Number: DYNJ83461; ii. VNUS, Model Number: CDS984292I; jj. VNUS CLOSURE, Model Number: DYNJ66076; kk. VNUS VASCULAR PACK, Model Number: DYNJ66445; ll. WA VASCULAR PACK-LF, Model Number: DYNJ33612G

Z-2303-2023
Recall number
Z-2303-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
100,549 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ22350K, UPC Number: 019348956435; Model Number: DYNJ22350L, UPC Number: 019348944525; Model Number: DYNJ22676J, UPC Number: 019348956435; Model Number: DYNJ23445F, UPC Number: 019532715035; Model Number: DYNJ31902L, UPC Number: 019348956435; Model Number: DYNJ31902M, UPC Number: 019532729658; Model Number: DYNJ39432I, UPC Number: 019348933454; Model Number: DYNJ39432J, UPC Number: 019532710115; Model Number: DYNJ39432K, UPC Number: 019532730509; Model Number: DYNJ41625B, UPC Number: 088994293420; Model Number: DYNJ46246A, UPC Number: 088994258496; Model Number: DYNJ53438A, UPC Number: 019348965302; Model Number: DYNJ53610C, UPC Number: 019348930032; Model Number: DYNJ53995G, UPC Number: 019532707376; Model Number: DYNJ56791A, UPC Number: 019348959411; Model Number: DYNJ56791B, UPC Number: 019532704567; Model Number: DYNJ57490A, UPC Number: 019348964199; Model Number: DYNJ58608, UPC Number: 088994287195; Model Number: DYNJ58681A, UPC Number: 088827779848; Model Number: DYNJ58681B, UPC Number: 019532729337; Model Number: DYNJ58710, UPC Number: 088994288085; Model Number: DYNJ61325A, UPC Number: 019348979445; Model Number: DYNJ61325B, UPC Number: 019532709784; Model Number: DYNJ61528, UPC Number: 019348957898; Model Number: DYNJ62399A, UPC Number: 019348925026; Model Number: DYNJ65160, UPC Number: 019348925092; Model Number: DYNJ66356, UPC Number: 019348934445; Model Number: DYNJ66356A, UPC Number: 019348983939; Model Number: DYNJ66356B, UPC Number: 019348994135; Model Number: DYNJ66356C, UPC Number: 019348999105; Model Number: DYNJ66356D, UPC Number: 019532706029; Model Number: DYNJ66577, UPC Number: 019348936096; Model Number: DYNJ68492A, UPC Number: 019348991395; Model Number: DYNJ68492B, UPC Number: 019532703330; Model Number: DYNJ68492C, UPC Number: 019532720566; Model Number: DYNJ68492D, UPC Number: 019532734221; Model Number: DYNJ68863, UPC Number: 019348984540; Model Number: DYNJ68863A, UPC Number: 019532702645; Model Number: DYNJ68880, UPC Number: 019348984772; Model Number: DYNJ80599, UPC Number: 019532705334; Model Number: DYNJ81626, UPC Number: 019532712706; Model Number: DYNJ82016, UPC Number: 019532716359; Model Number: DYNJ82104, UPC Number: 019532717108; Model Number: DYNJ82144, UPC Number: 019532717803; Model Number: DYNJ82769, UPC Number: 019532720722; Model Number: DYNJ82769A, UPC Number: 019532735023; Model Number: DYNJ83146, UPC Number: 019532723568. b. Model Number: DYNJ59778A, UPC Number: 019348959858; Model Number: DYNJ59778B, UPC Number: 019348969592. c. Model Number: DYNJ59245, UPC Number: 088827776727; Model Number: DYNJ59245A, UPC Number: 019532703914. d. Model Number: DYNJ39866B, UPC Number: 088994270504; Model Number: DYNJ39866C, UPC Number: 019532717634. e. Model Number: DYNJ68404, UPC Number: 019348983069. f. Model Number: DYNJ0250564O, UPC Number: 019348956435; Model Number: DYNJ0250564P, UPC Number: 019532708884; Model Number: DYNJ0373040N, UPC Number: 019348987387; Model Number: DYNJ0493141G, UPC Number: 019348956435; Model Number: DYNJ0493141I, UPC Number: 019348956435; Model Number: DYNJ0493141J, UPC Number: 019348992622; Model Number: DYNJ0871182AC, UPC Number: 019532733085; Model Number: DYNJ0901358I, UPC Number: 019348956435; Model Number: DYNJ0901358J, UPC Number: 019348956435; Model Number: DYNJ0901358K, UPC Number: 019532734322; Model Number: DYNJ53475F, UPC Number: 019348942486; Model Number: DYNJ53684A, UPC Number: 019348938687; Model Number: PHS400047N, UPC Number: 019348996690; Model Number: PHS400047O, UPC Number: 019532712350. g. Model Number: DYNJ906440A, UPC Number: 019348931287. h. Model Number: DYNJ56858, UPC Number: 088994268907. i. Model Number: DYNJ905079F, UPC Number: 019532720900. j. Model Number: DYNJ900714B, UPC Number: 019348922643; Model Number: DYNJ900714C, UPC Number: 019348995136. k. Model Number: DYNJ52586B, UPC Number: 019532721211. l. Model Number: DYNJ52586, UPC Number: 088994229774; Model Number: DYNJ52586A, UPC Number: 019348949439; Model Number: DYNJ52586B, UPC Number: 019532721211. m. Model Number: DYNJ69272A, UPC Number: 019532701580. n. Model Number: DYNJ62889, UPC Number: 019348969667. o. Model Number: DYNJ64396, UPC Number: 019348981050. p. Model Number: DYNJ49874, UPC Number: 088827789060. q. Model Number: DYNJ52123, UPC Number: 088994224214. r. Model Number: DYNJ68667, UPC Number: 019348983731. s. Model Number: DYNJ35586G, UPC Number: 019348966323; Model Number: DYNJ39408F, UPC Number: 019348969283; Model Number: DYNJ65189B, UPC Number: 019348943314. t. Model Number: DYNJ44737B, UPC Number: 019348935171. u. Model Number: DYNJ57047, UPC Number: 088994271048. v. Model Number: DYNJ64190, UPC Number: 019348979335. w. Model Number: DYNJ65560A, UPC Number: 019348939718. x. Model Number: DYNJ21949J, UPC Number: 088994212841; Model Number: DYNJ39005B, UPC Number: 019348956435; Model Number: DYNJ39889, UPC Number: 088438979693; Model Number: DYNJ48493, UPC Number: 088827759997; Model Number: DYNJ48907F, UPC Number: 088994252942; Model Number: DYNJ50785, UPC Number: 088994210530; Model Number: DYNJ52098, UPC Number: 088994223706; Model Number: DYNJ52993A, UPC Number: 019348936103; Model Number: DYNJ53160, UPC Number: 088994238558; Model Number: DYNJ53160A, UPC Number: 019348974565; Model Number: DYNJ54153B, UPC Number: 088994271442; Model Number: DYNJ55268, UPC Number: 088994253967; Model Number: DYNJ55462A, UPC Number: 019348928316; Model Number: DYNJ55514A, UPC Number: 088994272740; Model Number: DYNJ55849A, UPC Number: 088994268001; Model Number: DYNJ56624, UPC Number: 088994266543; Model Number: DYNJ56724A, UPC Number: 088994282388; Model Number: DYNJ56724B, UPC Number: 019348946631; Model Number: DYNJ57512, UPC Number: 088994274827; Model Number: DYNJ57835, UPC Number: 088994278233; Model Number: DYNJ57917, UPC Number: 088994279429; Model Number: DYNJ58063, UPC Number: 088994281667; Model Number: DYNJ58609, UPC Number: 088994287126; Model Number: DYNJ59151F, UPC Number: 019348948756; Model Number: DYNJ59662B, UPC Number: 019348943433; Model Number: DYNJ59662D, UPC Number: 019532703087; Model Number: DYNJ59677A, UPC Number: 019348961635; Model Number: DYNJ59681A, UPC Number: 019348946987; Model Number: DYNJ61540C, UPC Number: 019348949512; Model Number: DYNJ63823, UPC Number: 019348976342; Model Number: DYNJ64282, UPC Number: 019348979637; Model Number: DYNJ64471A, UPC Number: 019348941415; Model Number: DYNJ65579, UPC Number: 019348928038; Model Number: DYNJ66154, UPC Number: 019348931778; Model Number: DYNJ66743A, UPC Number: 019348943555; Model Number: DYNJ68749, UPC Number: 019348983668; Model Number: DYNJ69091, UPC Number: 019348988372; Model Number: DYNJ80199A, UPC Number: 019532704086; Model Number: DYNJ80199B, UPC Number: 019532708820; Model Number: DYNJ80868, UPC Number: 019532708250; Model Number: DYNJ83147, UPC Number: 019532723550. y. Model Number: DYNJ66427, UPC Number: 019348935468. z. Model Number: DYNJ66271A, UPC Number: 019348981468; Model Number: DYNJ66271C, UPC Number: 019532709850. aa. Model Number: DYNJ65342A, UPC Number: 019348936966. bb. Model Number: DYNJ38264D, UPC Number: 019348943849; Model Number: DYNJ62038A, UPC Number: 019348932240; Model Number: DYNJ64909, UPC Number: 019348923016. cc. Model Number: DYNJ53616A, UPC Number: 088994268856. dd. Model Number: DYNJ57003, UPC Number: 088994270310; Model Number: DYNJ62829A, UPC Number: 019348930662. ee. Model Number: DYNJ50227C, UPC Number: 088994293861. ff. Model Number: DYNJ61010A, UPC Number: 019348930714. gg. Model Number: DYNJ44421D, UPC Number: 019348948263. hh. Model Number: DYNJ83461, UPC Number: 019532726779. ii. Model Number: CDS984292I, UPC Number: 019348986248. jj. Model Number: DYNJ66076, UPC Number: 019348931923. kk. Model Number: DYNJ66445, UPC Number: 019348935608. ll. Model Number: DYNJ33612G, UPC Number: 019532720495.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 15 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510; d. OR CATHETER INSERTION SETUP PACK, Model Number: ECVC7165A; e. VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number: STCVC01145B; f. VANTEX TRIPLE LUMEN BUNDLE, Model Number: STCVC2000;

Z-2304-2023
Recall number
Z-2304-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
1,218 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: STCVC2020, UPC Number: 10653160338765. b. Model Number: ART905, UPC Number: 10653160326557. c. Model Number: CVI4510, UPC Number: 10653160321194. d. Model Number: ECVC7165A, UPC Number: 10653160346760. e. Model Number: STCVC01145B, UPC Number: 10653160351924. f. Model Number: STCVC2000, UPC Number: 10653160336792.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 16 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Number: DYNJ49235D; i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G; j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945; k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178; l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167; m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W; n. BARIATRIC KIT, Model Number: DYNJ901145F; o. BASIC VEIN PACK, Model Number: DYNJ69426; p. BCH VEIN ABLATION, Model Number: DYNJ69796; q. CATH LAB-VEIN PROCEDURES, Model Number: DYNJ60329A; r. CENTRAL LINE BUNDLE PACK-LF, Model Number: DYNJ22338K; s. CENTRAL LINE INSERTION KIT, Model Number: DYNJ52894A; t. CENTRAL LINE INSERTION PACK, Model Number: CVI4805; u. CENTRAL LINE KIT, Model Number: DYNDC2582A; v. CENTRAL LINE KIT UTMB, Model Number: DYNDC3061; w. CENTRAL LINE PACK, Model Number: DYNJ30087C, DYNJ48096B; x. CENTRAL LINE PACK-LF, Model Number: DYNJ0220136Q; y. CENTRAL LINE PLACEMENT PACK-LF, Model Number: DYNJ32358G; z. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; aa. CENTRAL LINE TRAY, Model Number: CVI4705; bb. CENTRAL VENOUS ACCESS PACK-LF, Model Number: DYNJ0214541O; cc. CVC/PICC INSERTION PACK EH-LF, Model Number: DYNJ40204A, DYNJ40204B; dd. CVL PACK, Model Number: DYNJ00281O; ee. CVR ENDOVENOUS PACK, Model Number: DYNJ80643; ff. DBD-AV FISTULA, Model Number: DYNJ904398D; gg. DBD-CENTRAL LINE TRAY, Model Number: DYNJ42902C; hh. DBD-LEE VEIN PACK, Model Number: DYNJ54906C; ii. DBD-PICC LINE PACK-LF, Model Number: DYNJ0373077O; jj. DBD-VARICOSE VEIN PACK, Model Number: DYNJ82884, DYNJ82885; kk. DBD-VASCULAR PACK-LF, Model Number: DYNJ56968; ll. DBD-VASCULAR VEIN PACK, Model Number: DYNJ69769; mm. DBD-VEIN PACK, Model Number: DYNJ82033; nn. DBD-VENCLOSE PROCEDURE PACK, Model Number: DYNJ80123; oo. DBD-VENOUS ACCESS PORT INSERTION, Model Number: DYNJ902602I; pp. DBD-VENOUS PACK, Model Number: DYNJ44243C, DYNJ80692; qq. DECLOT ACCESS, Model Number: DYNJ907279A, DYNJ907279B; rr. DEXMED ACCESS PACK, Model Number: DYNJ83148; ss. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435D; tt. ENS PICC LINE-HEJ-LF, Model Number: DYNJ67606; uu. ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; vv. ER CENTRAL LINE KIT, Model Number: P155508D; ww. FISTULA SAVANNAH PACK, Model Number: DYNJ69943; xx. FISTULAGRAM PACK-LF, Model Number: DYNJ63213; yy. FNA TRAY, Model Number: DYNDH1123B; zz. GENERAL AV FISTULA, Model Number: DYNJ906011B; aaa. GROTH LASER VEIN CDS, Model Number: CDS984193Q; bbb. I.R. PICC PACK, Model Number: DYNDA2759; ccc. IR CENTRAL VENOUS ACCESS, Model Number: DYNJ43267G; ddd. IR PICC TRAY, Model Number: DYNDH1223; eee. JVL-PACK PICC, Model Number: DYNJ66062; fff. KIT MAJOR VASCULAR, Model Number: DYNJ907262A; ggg. KIT VEIN ABLATION, Model Number: DYNJ907381; hhh. LASER VEIN EC PACK, Model Number: DYNJ82951; iii. MAX BARRIER ART LINE KIT, Model Number: ART950; jjj. MHC AV FISTULA, Model Number: DYNJ903705G; kkk. MID HUDSON PICC LINE PACK, Model Number: DYNJ53618A; lll. MIDLINE INSERTION KIT, Model Number: DYNJ45178; mmm. MSB BEDSIDE TRAY, Model Number: DYNJ54670; nnn. MV-IR-PICC PACK-LF, Model Number: DYNJ41554C; ooo. NENTRAL LINE TRAY, Model Number: DYNJ42902D; ppp. NEONATAL PICC LINE TRAY, Model Number: DYNDC2120B; qqq. OPEN VASCULA

Z-2305-2023
Recall number
Z-2305-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
146,157 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ65711, UPC Number: 019348928509. b. Model Number: DYNJ64141A, UPC Number: 019532727957. c. Model Number: DYNJ40682B, UPC Number: 088994226721. d. Model Number: DYNDA2482, UPC Number: 019348935160. e. Model Number: DYNJ67534, UPC Number: 019348940932. f. Model Number: DYNJ81725, UPC Number: 019532713675. g. Model Number: ART900, UPC Number: 065316034254. h. Model Number: DYNJ49235D, UPC Number: 019348989433. i. Model Number: DYNJ53095A, UPC Number: 019532714872; Model Number: DYNJ55169G, UPC Number: 019348996756. j. Model Number: DYNJ64143A, UPC Number: 019348928481; Model Number: DYNJ905219A, UPC Number: 019348928721; Model Number: DYNJ906341C, UPC Number: 019348981630; Model Number: DYNJ906945, UPC Number: 019348929927. k. Model Number: DYNJ52093I, UPC Number: 019348933747; Model Number: DYNJ62733, UPC Number: 019348968502; Model Number: DYNJ66916, UPC Number: 019348938765; Model Number: DYNJ67178, UPC Number: 019348941674. l. Model Number: DYNJ48428C, UPC Number: 019348970247; Model Number: DYNJ64499A, UPC Number: 019348986330; Model Number: DYNJ69167, UPC Number: 019348989918. m. Model Number: DYNJ0781844W, UPC Number: 019348922653. n. Model Number: DYNJ901145F, UPC Number: 019348932609. o. Model Number: DYNJ69426, UPC Number: 019348993939. p. Model Number: DYNJ69796, UPC Number: 019348997935. q. Model Number: DYNJ60329A, UPC Number: 019348997222. r. Model Number: DYNJ22338K, UPC Number: 019348936830. s. Model Number: DYNJ52894A, UPC Number: 088994243754. t. Model Number: CVI4805, UPC Number: 019532706871. u. Model Number: DYNDC2582A, UPC Number: 019348934939. v. Model Number: DYNDC3061, UPC Number: 019348949581. w. Model Number: DYNJ30087C, UPC Number: 088994275414; Model Number: DYNJ48096B, UPC Number: 088827793931. x. Model Number: DYNJ0220136Q, UPC Number: 019348982348. y. Model Number: DYNJ32358G, UPC Number: 088994252647. z. Model Number: DT22260, UPC Number: 065316032919. aa. Model Number: CVI4705, UPC Number: 019348983237. bb. Model Number: DYNJ0214541O, UPC Number: 019532708888. cc. Model Number: DYNJ40204A, UPC Number: 088994240964; Model Number: DYNJ40204B, UPC Number: 019532717845. dd. Model Number: DYNJ00281O, UPC Number: 019348996296. ee. Model Number: DYNJ80643, UPC Number: 019532705579. ff. Model Number: DYNJ904398D, UPC Number: 019348970132. gg. Model Number: DYNJ42902C, UPC Number: 019532708468. hh. Model Number: DYNJ54906C, UPC Number: 019532718876. ii. Model Number: DYNJ0373077O, UPC Number: 088994236495. jj. Model Number: DYNJ82884, UPC Number: 019532721599; Model Number: DYNJ82885, UPC Number: 019532721600. kk. Model Number: DYNJ56968, UPC Number: 088994269923. ll. Model Number: DYNJ69769, UPC Number: 019348997779. mm. Model Number: DYNJ82033, UPC Number: 019532716297. nn. Model Number: DYNJ80123, UPC Number: 019532700918. oo. Model Number: DYNJ902602I, UPC Number: 019348989256. pp. Model Number: DYNJ44243C, UPC Number: 019348970140; Model Number: DYNJ80692, UPC Number: 019532706554. qq. Model Number: DYNJ907279A, UPC Number: 019348990771; Model Number: DYNJ907279B, UPC Number: 019532711639. rr. Model Number: DYNJ83148, UPC Number: 019532723551. ss. Model Number: DYNJ53435D, UPC Number: 019532719644. tt. Model Number: DYNJ67606, UPC Number: 019348942167. uu. Model Number: DYNJ65827, UPC Number: 019348929849. vv. Model Number: P155508D, UPC Number: 019348989906. ww. Model Number: DYNJ69943, UPC Number: 019348999844. xx. Model Number: DYNJ63213, UPC Number: 019348972821. yy. Model Number: DYNDH1123B, UPC Number: 019348946555. zz. Model Number: DYNJ906011B, UPC Number: 019348941123. aaa. Model Number: CDS984193Q, UPC Number: 019532725508. bbb. Model Number: DYNDA2759, UPC Number: 019348948819. ccc. Model Number: DYNJ43267G, UPC Number: 019532728880. ddd. Model Number: DYNDH1223, UPC Number: 10889942567539. eee. Model Number: DYNJ66062, UPC Number: 019348931921. fff. Model Number: DYNJ907262A, UPC Number: 019348990913. ggg. Model Number: DYNJ907381, UPC Number: 019348990077. hhh. Model Number: DYNJ82951, UPC Number: 019532721897. iii. Model Number: ART950, UPC Number: 065316033022. jjj. Model Number: DYNJ903705G, UPC Number: 019348934550. kkk. Model Number: DYNJ53618A, UPC Number: 088994249249. lll. Model Number: DYNJ45178, UPC Number: 088827709574. mmm. Model Number: DYNJ54670, UPC Number: 088994249957. nnn. Model Number: DYNJ41554C, UPC Number: 088994281132. ooo. Model Number: DYNJ42902D, UPC Number: 019532717110. ppp. Model Number: DYNDC2120B, UPC Number: 019348936335. qqq. Model Number: DYNJ907858, UPC Number: 019348990935. rrr. Model Number: DYNJ81592, UPC Number: 019532712377. sss. Model Number: DYNJ81669, UPC Number: 019532713232; Model Number: DYNJ81669B, UPC Number: 019532725343. ttt. Model Number: CVI3650, UPC Number: 065316025639. uuu. Model Number: MNS13555, UPC Number: 065316099195. vvv. Model Number: DYNJ40990C, UPC Number: 088994202437. www. Model Number: DYNJ39039M, UPC Number: 019348989850. xxx. Model Number: GSS584Q, UPC Number: 019348994102. yyy. Model Number: CVI3830, UPC Number: 065316026994; Model Number: CVI4025A, UPC Number: 019348939605. zzz. Model Number: DYNJ60038A, UPC Number: 019532703833; Model Number: DYNJ61637, UPC Number: 019348958546. aaaa. Model Number: DYNJ40206A, UPC Number: 088827702610; Model Number: DYNJ40206B, UPC Number: 019532717644. bbbb. Model Number: DYNJ67415, UPC Number: 019348993088. cccc. Model Number: DYNJ51852B, UPC Number: 088994248122. dddd. Model Number: DYNJ70141MB, UPC Number: 088994272280. eeee. Model Number: DYNJ70152MB, UPC Number: 088994272282. ffff. Model Number: DYNJ55546C, UPC Number: 019348927672; Model Number: DYNJ55546D, UPC Number: 019532705652; Model Number: DYNJ64337, UPC Number: 019348980028. gggg. Model Number: DYNJ38868K, UPC Number: 019348956435; Model Number: DYNJ38868L, UPC Number: 019532722477. hhhh. Model Number: DYNJ34241, UPC Number: 088438933586. iiii. Model Number: DYNJ04592K, UPC Number: 019348921520; Model Number: DYNJ17017F, UPC Number: 019348956435; Model Number: DYNJ30233C, UPC Number: 019348938257; Model Number: DYNJ44089A, UPC Number: 088994249268; Model Number: DYNJ47037C, UPC Number: 019348961600; Model Number: DYNJ55170, UPC Number: 088994253218; Model Number: DYNJ55170A, UPC Number: 019348990860; Model Number: DYNJ55170B, UPC Number: 019348996757; Model Number: DYNJ55170C, UPC Number: 019532713535; Model Number: DYNJ64249A, UPC Number: 019348938136; Model Number: DYNJ65903, UPC Number: 019348930065. jjjj. Model Number: DYNJ0235859I, UPC Number: 019348956435; Model Number: DYNJ0235859J, UPC Number: 019532706927; Model Number: DYNJ0235859K, UPC Number: 019532724321; Model Number: DYNJ0678523M, UPC Number: 019348956435; Model Number: DYNJ0678523N, UPC Number: 019348999404; Model Number: DYNJ0855123N, UPC Number: 019532709488; Model Number: DYNJ21575G, UPC Number: 019348956435; Model Number: DYNJ21575I, UPC Number: 019532700967. kkkk. Model Number: DYNJ52688B, UPC Number: 019348945247; Model Number: DYNJ52688C, UPC Number: 019532730102; Model Number: DYNJ64725B, UPC Number: 019348945284. llll. Model Number: DYNJT2272J, UPC Number: 019348926312; Model Number: DYNJT2272K, UPC Number: 019532725067. mmmm. Model Number: DYNJ47717B, UPC Number: 019532735530. nnnn. Model Number: DYNJ35323, UPC Number: 019348956435. oooo. Model Number: DYNJ30566B, UPC Number: 088994237552; Model Number: DYNJ52255, UPC Number: 088994225370; Model Number: DYNJ60990A, UPC Number: 019348948445; Model Number: DYNJ60990B, UPC Number: 019348992170; Model Number: DYNJ65838, UPC Number: 019348930326; Model Number: DYNJ69088, UPC Number: 019348988361; Model Number: DYNJ69088A, UPC Number: 019348997524. pppp. Model Number: DYNJ0940720D, UPC Number: 088994255095; Model Number: DYNJ17086A, UPC Number: 088438906430; Model Number: DYNJ35000I, UPC Number: 019348926164; Model Number: DYNJ48120B, UPC Number: 088827789487; Model Number: DYNJ63162, UPC Number: 019348972089. qqqq. Model Number: DYNDC2373A, UPC Number: 088994249220. rrrr. Model Number: DYNJ33005D, UPC Number: 019348956435; Model Number: DYNJ33005F, UPC Number: 019348956435; Model Number: DYNJ35272, UPC Number: 088438942826; Model Number: DYNJ41648, UPC Number: 088438990917; Model Number: PICCNC0008, UPC Number: 019532722158. ssss. Model Number: DYNJ63590, UPC Number: 019348976918. tttt. Model Number: DYNJ31725A, UPC Number: 019348956435. uuuu. Model Number: DYNJ81726, UPC Number: 019532713677. vvvv. Model Number: DYNJ81284, UPC Number: 019532710571. wwww. Model Number: DYNJ35163C, UPC Number: 088994249468; Model Number: DYNJ56857A, UPC Number: 088994274727; Model Number: DYNJ56857C, UPC Number: 019348996758. xxxx. Model Number: DYNJ65775, UPC Number: 019348928982. yyyy. Model Number: DYNJ83534, UPC Number: 019532727671. zzzz. Model Number: DYNJ61894B, UPC Number: 019532700387.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 17 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989; d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267; e. TV IR PICC PACK-LF, Model Number: DYNJ41561D; f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A; g. ULTRASOUND GUIDED PIV KIT, Model Number: DYNDA2669; h. USG PIV INSERTION KIT, Model Number: DYNDV2480; i. VASCULAR, Model Number: DYNJ907965; j. VASCULAR ACCESS, Model Number: DYNJ901340A; k. VASCULAR ACCESS TRAY, Model Number: DYNJ52606B; l. VASCULAR ACCESS-LF, Model Number: DYNJ905285D; m. VASCULAR ENDO LASER PK, Model Number: DYNJ37445G; n. VASCULAR PACK, Model Number: DYNJ66356F; o. VASCULAR VEIN PACK, Model Number: DYNJ69769; p. VEIN ABLATION, Model Number: DYNJ63268C, DYNJ63268D, DYNJ66079A; q. VEIN ABLATION KIT, Model Number: DYNJ69272; r. VEIN ABLATION PACK, Model Number: DYNJ62889A, DYNJ62889B, DYNJ69288; s. VEIN ABLATION PLUS W CHL, Model Number: DYNJ67115A; t. VEIN CLOSURE, Model Number: DYNJ49180A; u. VEIN CLOSURE PACK, Model Number: DYNJ69976, DYNJ69976A, DYNJ81834; v. VEIN CLOSURE TRAY - NIVC, Model Number: DYNJ44737C; w. VEIN HARVESTING PACK, Model Number: DYNJ82933; x. VEIN LIGATION, Model Number: DYNJ64190B; y. VEIN OHH, Model Number: DYNJ65560C; z. VEIN PACK, Model Number: DYNJ66743B, DYNJ69091A, DYNJ69091B, DYNJ69177, DYNJ69942, DYNJ69942A, DYNJ81120, DYNJ81212A, DYNJ83914; aa. VEIN PACK-LF, Model Number: DYNJ66271B, DYNJ66271D; bb. VEIN PROCEDURE PACK, Model Number: DYNJ62038B, DYNJ81177; cc. VEIN PROCEDURE TRAY, Model Number: DYNJ82581; dd. VENCLOSE PROCEDURE PACK 7CM, Model Number: VC-PPH-6F7A; ee. VENCLOSE PROCEDURE PACK MAVEN, Model Number: VC-PPM-12F; ff. VENCLOSE PROCEDURE PACK, 12CM, Model Number: VC-PP-6F12, VC-PPH-6F12A; gg. VENOUS ABLATION, Model Number: DYNJ44904B, DYNJ44904C; hh. VENOUS ACCESS, Model Number: DYNJ59751B; ii. VENOUS ACCESS PACK, Model Number: DYNJ44421B; jj. VENOUS ACCESS TRAY, Model Number: DYNJ20094L; kk. VENOUS LIGATION PACK, Model Number: DYNJ43981G; ll. VENOUS PACK, Model Number: DYNJ43168, DYNJ43168A, DYNJ43168B, DYNJ56260A, DYNJ56447B, DYNJ62711A, DYNJ66499A, DYNJ66499B, DYNJ80169, DYNJ80169A, DYNJ80692; mm. VNUS PACK, Model Number: DYNJ59246A; nn. WEST VALLEY PICC LINE PACK, Model Number: DYNJ43975A;

Z-2306-2023
Recall number
Z-2306-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
148,445 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ57112, UPC Number: 088994272159. b. Model Number: DYNJSPICC2, UPC Number: 019348926312; Model Number: PICCNC002, UPC Number: 019348987719. c. Model Number: DYNJ82989, UPC Number: 019532722176. d. Model Number: DYNJ81267, UPC Number: 019532710144. e. Model Number: DYNJ41561D, UPC Number: 088994281163. f. Model Number: IVS3635A, UPC Number: 019348936055. g. Model Number: DYNDA2669, UPC Number: 019348946542. h. Model Number: DYNDV2480, UPC Number: 019348994276. i. Model Number: DYNJ907965, UPC Number: 019348995225. j. Model Number: DYNJ901340A, UPC Number: 088994217977. k. Model Number: DYNJ52606B, UPC Number: 088827776311. l. Model Number: DYNJ905285D, UPC Number: 019532706266. m. Model Number: DYNJ37445G, UPC Number: 019348956435. n. Model Number: DYNJ66356F, UPC Number: 019532716001. o. Model Number: DYNJ69769, UPC Number: 019348997779. p. Model Number: DYNJ63268C, UPC Number: 019532707716; Model Number: DYNJ63268D, UPC Number: 019532713221; Model Number: DYNJ66079A, UPC Number: 019348992307. q. Model Number: DYNJ69272, UPC Number: 019348992033. r. Model Number: DYNJ62889A, UPC Number: 019348997112; Model Number: DYNJ62889B, UPC Number: 019532703095; Model Number: DYNJ69288, UPC Number: 019348992267. s. Model Number: DYNJ67115A, UPC Number: 019532709188. t. Model Number: DYNJ49180A, UPC Number: 088827786356. u. Model Number: DYNJ69976, UPC Number: 019532700130; Model Number: DYNJ69976A, UPC Number: 019532713039; Model Number: DYNJ81834, UPC Number: 019532714785. v. Model Number: DYNJ44737C, UPC Number: 019532727787. w. Model Number: DYNJ82933, UPC Number: 019532721933. x. Model Number: DYNJ64190B, UPC Number: 019532728128. y. Model Number: DYNJ65560C, UPC Number: 019532713681. z. Model Number: DYNJ66743B, UPC Number: 019348994979, Model Number: DYNJ69091A, UPC Number: 019348996976, Model Number: DYNJ69091B, UPC Number: 019532717899, Model Number: DYNJ69177, UPC Number: 019348990219, Model Number: DYNJ69942, UPC Number: 019348999843, Model Number: DYNJ69942A, UPC Number: 019532728462, Model Number: DYNJ81120, UPC Number: 019532708588, Model Number: DYNJ81212A, UPC Number: 019532715986, Model Number: DYNJ83914, UPC Number: 019532731312. aa. Model Number: DYNJ66271B, UPC Number: 019348999891; Model Number: DYNJ66271D, UPC Number: 019532713074. bb. Model Number: DYNJ62038B, UPC Number: 019348989849; Model Number: DYNJ81177, UPC Number: 019532708961. cc. Model Number: DYNJ82581, UPC Number: 019532719865. dd. Model Number: VC-PPH-6F7A, UPC Number: 019348942309. ee. Model Number: VC-PPM-12F, UPC Number: 019348942268. ff. Model Number: VC-PP-6F12, UPC Number: 019348957665; Model Number: VC-PPH-6F12A, UPC Number: 019348942310. gg. Model Number: DYNJ44904B, UPC Number: 019348969532; Model Number: DYNJ44904C, UPC Number: 019348985867. hh. Model Number: DYNJ59751B, UPC Number: 019348969591. ii. Model Number: DYNJ44421B, UPC Number: 088994220519. jj. Model Number: DYNJ20094L, UPC Number: 019532721290. kk. Model Number: DYNJ43981G, UPC Number: 019348922353. ll. Model Number: DYNJ43168, UPC Number: 088827703489; Model Number: DYNJ43168A, UPC Number: 019532708470; Model Number: DYNJ43168B, UPC Number: 019532722452; Model Number: DYNJ56260A, UPC Number: 088994275590; Model Number: DYNJ56447B, UPC Number: 019348946406; Model Number: DYNJ62711A, UPC Number: 019348923301; Model Number: DYNJ66499A, UPC Number: 019348997752; Model Number: DYNJ66499B, UPC Number: 019532724210; Model Number: DYNJ80169, UPC Number: 019532701344; Model Number: DYNJ80169A, UPC Number: 019532716974; Model Number: DYNJ80692, UPC Number: 019532706554. mm. Model Number: DYNJ59246A, UPC Number: 019532703911. nn. Model Number: DYNJ43975A, UPC Number: 088827788244.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 18 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485; d. BIOPSY PACK-LF, Model Number: DYNJ0747885G; e. BIOPSY RAD CT, Model Number: DYNJ59752A; f. BIOPSY TRAY, Model Number: DYNDH1748, DYNJ34637F, DYNJ34637G, DYNJ43076, DYNJ43076A, DYNJ62690; g. BIOPSY WITH PROB COVER WRO-LF, Model Number: DYNJ42307A; h. BREAST BIOPSY KIT, Model Number: DYNDA1224B; i. BREAST BIOPSY TRAY, Model Number: DYNDH1266, DYNDH1302, DYNDH1345A, DYNDH1677; j. CABARRUS BIOPSY TRAY, Model Number: DYNDH1670; k. CORE BIOPSY PACK-LF, Model Number: DYNJ42752A; l. GENERAL BIOPSY PACK, Model Number: P365500; m. IGT BIOPSY PACK-LF, Model Number: DYNJ38616A; n. IR BIOPSY PACK, Model Number: DYNJ63688I; o. PROSTATE BIOPSY, Model Number: DYNJVB91015A; p. PROSTATE BIOPSY PACK, Model Number: DYNJ56578; q. RENAL BIOPSY TRAY, Model Number: SPEC0168; r. REVAMP BIOPSY TRAY, Model Number: DYNDH1147A; s. SOFT TISSUE BIOPSY, Model Number: DYNDH1750; t. THYROID BIOPSY TRAY, Model Number: DYNDH1288; u. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; v. UL BIOPSY TRAY, Model Number: DYNDH1778; w. ULTRASOUND BIOPSY, Model Number: DYNDH1542B; x. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496A; y. ULTRASOUND CORE BIOPSY TRAY, Model Number: DYNDH1786; z. US BREAST BIOPSY PACK, Model Number: DYNJ61992B;

Z-2307-2023
Recall number
Z-2307-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
43,613 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ53658B, UPC Number: 019532708870. b. Model Number: DYNDH1534, UPC Number: 019348919708. c. Model Number: DYNDH1124, UPC Number: 088994230327; Model Number: DYNJ50485, UPC Number: 088827799279; Model Number: DYNDH1124, UPC Number: 10889942303274. d. Model Number: DYNJ0747885G, UPC Number: 019532708872. e. Model Number: DYNJ59752A, UPC Number: 019348959857. f. Model Number: DYNDH1748, UPC Number: 019532716474; Model Number: DYNJ34637F, UPC Number: 019348956435; Model Number: DYNJ34637G, UPC Number: 019348936880; Model Number: DYNJ43076, UPC Number: 088827702453; Model Number: DYNJ43076A, UPC Number: 019532708062; Model Number: DYNJ62690, UPC Number: 019348968226. g. Model Number: DYNJ42307A, UPC Number: 088827729875. h. Model Number: DYNDA1224B, UPC Number: 019348946851. i. Model Number: DYNDH1266, UPC Number: 088994267045; Model Number: DYNDH1302, UPC Number: 088994276804; Model Number: DYNDH1345A, UPC Number: 088827773293; Model Number: DYNDH1677, UPC Number: 019532704448. j. Model Number: DYNDH1670, UPC Number: 019532701068. k. Model Number: DYNJ42752A, UPC Number: 088994232609. l. Model Number: P365500, UPC Number: 088994214185. m. Model Number: DYNJ38616A, UPC Number: 088438975595. n. Model Number: DYNJ63688I, UPC Number: 019532703723. o. Model Number: DYNJVB91015A, UPC Number: 019348933972. p. Model Number: DYNJ56578, UPC Number: 088994265947. q. Model Number: SPEC0168, UPC Number: 088438986986. r. Model Number: DYNDH1147A, UPC Number: 019348934879. s. Model Number: DYNDH1750, UPC Number: 019532716642. t. Model Number: DYNDH1288, UPC Number: 088994272663. u. Model Number: DYNDH1121C, UPC Number: 019348946865. v. Model Number: DYNDH1778, UPC Number: 019532722847. w. Model Number: DYNDH1542B, UPC Number: 019532725147. x. Model Number: DYNDH1496A, UPC Number: 019348982531. y. Model Number: DYNDH1786, UPC Number: 019532722955. z. Model Number: DYNJ61992B, UPC Number: 019532729265.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 19 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.

Z-2308-2023
Recall number
Z-2308-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
1,130 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: OST011F, UPC Number: 019532709134

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 20 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD-IR THYROID PACK THLUF642-LF, Model Number: DYNJ47716B; i. ENT FREE FLAP, Model Number: SYNJ910018A; j. ENT FREE FLAP PACK, Model Number: DYNJ67954A; k. FEM CAROTID PACK, Model Number: DYNJ65706; l. FLAP ENT FREE, Model Number: DYNJ905340A; m. FREE FLAP PACK-LF, Model Number: DYNJ20495J; n. PACK HEAD NECK, Model Number: DYNJ30245; o. SVMMC CAROTID PACK, Model Number: DYNJ43861D; p. TAVR FAIRFAX, Model Number: DYNJ63634A; q. VNUS TRAY, Model Number: DYNJ44410F;

Z-2309-2023
Recall number
Z-2309-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
3,431 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ54287A, UPC Number: 088994276521. b. Model Number: DYNJ66190, UPC Number: 019348932219. c. Model Number: DYNJ905622C, UPC Number: 019348926350. d. Model Number: DYNJ901745J, UPC Number: 019348960482. e. Model Number: DYNJ63347A, UPC Number: 019348927806. f. Model Number: CDS983069G, UPC Number: 019348992392. g. Model Number: CDS983069I, UPC Number: 019532707186. h. Model Number: DYNJ47716B, UPC Number: 019348945453. i. Model Number: SYNJ910018A, UPC Number: 019348937418. j. Model Number: DYNJ67954A, UPC Number: 019348995714. k. Model Number: DYNJ65706, UPC Number: 019348928490. l. Model Number: DYNJ905340A, UPC Number: 019348950213. m. Model Number: DYNJ20495J, UPC Number: 019348956435. n. Model Number: DYNJ30245, UPC Number: 008019678769. o. Model Number: DYNJ43861D, UPC Number: 088994276328. p. Model Number: DYNJ63634A, UPC Number: 019532714304. q. Model Number: DYNJ44410F, UPC Number: 019348981154.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 21 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;

Z-2310-2023
Recall number
Z-2310-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
4,618 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ906905B, UPC Number: 019348988494. b. Model Number: CDS840215O, UPC Number: 019348944899. c. Model Number: DYNJ906905A, UPC Number: 019348939112. d. Model Number: DYNDH1187A, UPC Number: 088994270263.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 22 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;

Z-2311-2023
Recall number
Z-2311-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
130 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ905655A, UPC Number: 019348992579.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 23 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O; e. BARIATRIC PACK, Model Number: DYNJ24459P; f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242; g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942; h. DBD-FETOSCOPIC, Model Number: DYNJ905761A; i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B; j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A; k. DIEP, Model Number: DYNJ901296B; l. DIEP FLAP, Model Number: DYNJ66867A; m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N; n. ECMO PACK, Model Number: DYNJ82517; o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B; p. ENDOVASCULAR, Model Number: DYNJ63343G; q. EVLT SURGICAL PACK, Model Number: DYNJ48520; r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q; s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C; t. FLAP HARVEST PACK, Model Number: DYNJ58575B; u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O; v. FREE FLAP, Model Number: DYNJ905634B; w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290; x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K; y. FREE FLAP BASIN PACK, Model Number: DYNJ69914; z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A; aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B; bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K; cc. GENERAL ANGIO PACK, Model Number: DYNJ57760; dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M; ee. HILLCREST PCNL PACK, Model Number: DYNJ69204; ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B; gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; hh. LAP CHOLE PACK, Model Number: DYNJ41208D; ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B; jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A; kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A; ll. MINOR, Model Number: DYNJ906915; mm. MINOR CV, Model Number: DYNJ69898A; nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A; pp. PCNL PACK, Model Number: DYNJ0569950Q; qq. PLANO DIEP PACK, Model Number: DYNJ81751; rr. PORT PACK, Model Number: DYNJ61747C; ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C; tt. PV MINOR PACK, Model Number: DYNJ63879D; uu. RF PACK, Model Number: DYNJ52505A; vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C; ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F; xx. ROBOTIC-LF, Model Number: DYNJ904254F; yy. ROBOTICS GYN, Model Number: DYNJ905824D; zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A; aaa. TAA AAA, Model Number: DYNJ63339C; bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B; ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;

Z-2312-2023
Recall number
Z-2312-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
16,143 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ40629B, UPC Number: 088827777869. b. Model Number: DYNJ81410B, UPC Number: 019532732082. c. Model Number: DYNJ901145G, UPC Number: 019348985021. d. Model Number: DYNJC9299M, UPC Number: 019348926312; Model Number: DYNJC9299O, UPC Number: 019532718840. e. Model Number: DYNJ24459P, UPC Number: 019348935534. f. Model Number: DYNJ36242, UPC Number: 088438951744. g. Model Number: DYNJ60667C, UPC Number: 019348940759; Model Number: DYNJ60667D, UPC Number: 019348986151; Model Number: DYNJ60667F, UPC Number: 019532702361; Model Number: DYNJ83942, UPC Number: 019532731798. h. Model Number: DYNJ905761A, UPC Number: 019348946321. i. Model Number: DYNJ68447B, UPC Number: 019532703416. j. Model Number: DYNJ69204A, UPC Number: 019532711427. k. Model Number: DYNJ901296B, UPC Number: 019348992335. l. Model Number: DYNJ66867A, UPC Number: 019348998623. m. Model Number: DYNJ0426069N, UPC Number: 019532737131. n. Model Number: DYNJ82517, UPC Number: 019532719864. o. Model Number: DYNJ44210B, UPC Number: 019348930685. p. Model Number: DYNJ63343G, UPC Number: 019532727346. q. Model Number: DYNJ48520, UPC Number: 088827790346. r. Model Number: CDS840214Q, UPC Number: 019532728990. s. Model Number: DYNJ907076A, UPC Number: 019348938164; Model Number: DYNJ907076B, UPC Number: 019348945045; Model Number: DYNJ907076C, UPC Number: 019348946561. t. Model Number: DYNJ58575B, UPC Number: 019348989550. u. Model Number: DYNJ0378388O, UPC Number: 019348956435. v. Model Number: DYNJ905634B, UPC Number: 019348963392. w. Model Number: DYNJ80290, UPC Number: 019532703724. x. Model Number: DYNJ0991320K, UPC Number: 019348956435. y. Model Number: DYNJ69914, UPC Number: 019348999641. z. Model Number: DYNJ68447, UPC Number: 019348944709; Model Number: DYNJ68447A, UPC Number: 019348991380. aa. Model Number: DYNJ68380, UPC Number: 019348943974; Model Number: DYNJ68380A, UPC Number: 019348991319; Model Number: DYNJ68380B, UPC Number: 019532703378. bb. Model Number: DYNJ0049595C, UPC Number: 019348980698; Model Number: DYNJ20495K, UPC Number: 019532737078. cc. Model Number: DYNJ57760, UPC Number: 088994277494. dd. Model Number: CDS982779L, UPC Number: 019348963341; Model Number: CDS982779M, UPC Number: 019348944627. ee. Model Number: DYNJ69204, UPC Number: 019348990830. ff. Model Number: DYNJ905366A, UPC Number: 019348975937; Model Number: DYNJ905366B, UPC Number: 019532704806. gg. Model Number: DYKMBNDL54A, UPC Number: 019532704487. hh. Model Number: DYNJ41208D, UPC Number: 019348929718. ii. Model Number: DYNJ80172, UPC Number: 019532701341; Model Number: DYNJ80172A, UPC Number: 019532712324; Model Number: DYNJ80172B, UPC Number: 019532735918. jj. Model Number: DYNJ68172A, UPC Number: 019348997493. kk. Model Number: DYNJ53059A, UPC Number: 088994241511. ll. Model Number: DYNJ906915, UPC Number: 019348928037. mm. Model Number: DYNJ69898A, UPC Number: 019532723505. nn. Model Number: DYNDA2418, UPC Number: 019348937821. oo. Model Number: DYNJ60242A, UPC Number: 019348924698. pp. Model Number: DYNJ0569950Q, UPC Number: 019348978281. qq. Model Number: DYNJ81751, UPC Number: 019532713931. rr. Model Number: DYNJ61747C, UPC Number: 019348936503. ss. Model Number: DYNJ908046C, UPC Number: 019532731349. tt. Model Number: DYNJ63879D, UPC Number: 019532722189. uu. Model Number: DYNJ52505A, UPC Number: 019348972485. vv. Model Number: DYNJ904219G, UPC Number: 019348948513; Model Number: DYNJ904343C, UPC Number: 019348982294. ww. Model Number: DYNJ904250F, UPC Number: 019348981399. xx. Model Number: DYNJ904254F, UPC Number: 019348945242. yy. Model Number: DYNJ905824D, UPC Number: 019348986150. zz. Model Number: DYNJRA0961A, UPC Number: 019348926312. aaa. Model Number: DYNJ63339C, UPC Number: 019348995807. bbb. Model Number: DYNJ41927B, UPC Number: 088994242830. ccc. Model Number: PHS751646C, UPC Number: 088994224535; Model Number: PHS751646D, UPC Number: 019532719680.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 24 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;

Z-2313-2023
Recall number
Z-2313-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
135 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: MNS10750A, UPC Number: 10653160356073. b. Model Number: CVI3845, UPC Number: 10653160270072.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 25 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;

Z-2314-2023
Recall number
Z-2314-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
80 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ60126B, UPC Number: 019532711883.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 26 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC1786A; d. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635B; e. USG PIV INSERTION KIT, Model Number: DYNDV2480A;

Z-2315-2023
Recall number
Z-2315-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
6,939 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CVI680C, UPC Number: 065316099294. b. Model Number: ECVC7880, UPC Number: 019532712961. c. Model Number: DYNDC1786A, UPC Number: 019348919911. d. Model Number: IVS3635B, UPC Number: 019348936055. e. Model Number: DYNDV2480A, UPC Number: 019532732721.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 27 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS PACK, Model Number: TVS4000K

Z-2316-2023
Recall number
Z-2316-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
6,733 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ46967F, UPC Number: 019348957604. b. Model Number: DYNJ64059, UPC Number: 019348978270. c. Model Number: DYNJ62557, UPC Number: 019348966915. d. Model Number: TVS4000K, UPC Number: 081698202386.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 28 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893; d. BREAST PACK, Model Number: DYNDH1306; e. BRST BX TRAY, Model Number: DYNDH1389B; f. CMC BREAST BIOPSY TRAY-LF, Model Number: DYNJ61084A; g. DBD-DIEP PACK, Model Number: DYNJ60669F; h. DBD-FREE FLAP, Model Number: DYNJ907802; i. DBD-FREE FLAP PACK, Model Number: DYNJ83286; j. DBD-MAJOR BREAST, Model Number: DYNJ905004B; k. DBD-PLASTICS FREE FLAP, Model Number: SYNJ910024A; l. DELNOR SIMPLE PLASTIC PACK, Model Number: DYNJ82250; m. DIEP, Model Number: DYNJ905702C, DYNJ905702D; n. DIEP FLAP CDS, Model Number: DYNJ904762D; o. DIEP PACK, Model Number: DYNJ60669C, DYNJ60669D; p. FH BREAST FLAP PACK, Model Number: DYNJ58272C, DYNJ58272D; q. FLAP KIT, Model Number: DYNJ900845B; r. FLAP PACK, Model Number: DYNJ48191G, DYNJ48191I, DYNJ48191J, DYNJ60224B; s. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388P; t. FREE FLAP, Model Number: DYNJ906823A, DYNJ906823B; u. FREE FLAP 1 PACK, Model Number: DYNJ82660; v. FREE FLAP 2 PACK, Model Number: DYNJ82659; w. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320L; x. FREE FLAP CDS, Model Number: CDS983996B; y. FREE FLAP CUSTOM PACK B, Model Number: DYNJ82736; z. FREE FLAP DONOR, Model Number: DYNJ44483B; aa. FREE FLAP PACK, Model Number: DYNJ83286; bb. FREE FLAP PACK-LF, Model Number: DYNJ0271254O, DYNJ20495I, DYNJ42833A, DYNJ42833B, PHS656679003; cc. FREE FLAP RECIPIENT, Model Number: DYNJ44484D, DYNJ44484F; dd. MAIN FLAP, Model Number: DYNJ908264; ee. MAJOR BREAST, Model Number: DYNJ905004A, DYNJ908890; ff. MINOR BREAST, Model Number: DYNJ905002B, DYNJ908892; gg. PK GEN BREAST RESTON, Model Number: DYNJ84305; hh. PLASTIC DIEP PACK, Model Number: DYNJ81727, DYNJ81727A; ii. PLASTIC FREE FLAP, Model Number: DYNJ67367, DYNJ67367A; jj. PLASTIC FREE FLAP PACK, Model Number: DYNJ82758; kk. PLASTIC MICROVASCULAR, Model Number: DYNJ908181, DYNJ908181A, DYNJ908181B; ll. PLASTIC PACK, Model Number: DYNJ35262A; mm. PROCEDURE PACK, Model Number: DYNJ55063; nn. RO-DIEP PACK, Model Number: DYNJ82393; oo. SDS MN BREAST PACK, Model Number: DYNJ57719C, DYNJ57719D; pp. VNUS RFS PROCEDURE PACK, Model Number: DYNJ39508A;

Z-2317-2023
Recall number
Z-2317-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
11,436 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ909031, UPC Number: 019532725061. b. Model Number: DYNJ904598B, UPC Number: 088994294635. c. Model Number: DYNJ63893, UPC Number: 019348977156. d. Model Number: DYNDH1306, UPC Number: 088994277152. e. Model Number: DYNDH1389B, UPC Number: 019348944918. f. Model Number: DYNJ61084A, UPC Number: 019348969202. g. Model Number: DYNJ60669F, UPC Number: 019532728956. h. Model Number: DYNJ907802, UPC Number: 019348989000. i. Model Number: DYNJ83286, UPC Number: 019532725665. j. Model Number: DYNJ905004B, UPC Number: 019348978258. k. Model Number: SYNJ910024A, UPC Number: 019348937448. l. Model Number: DYNJ82250, UPC Number: 019532718175. m. Model Number: DYNJ905702C, UPC Number: 019532700467; Model Number: DYNJ905702D, UPC Number: 019532717382. n. Model Number: DYNJ904762D, UPC Number: 019532725881. o. Model Number: DYNJ60669C, UPC Number: 019532702362; Model Number: DYNJ60669D, UPC Number: 019532721717. p. Model Number: DYNJ58272C, UPC Number: 019348989552; Model Number: DYNJ58272D, UPC Number: 019532714511. q. Model Number: DYNJ900845B, UPC Number: 088994263442. r. Model Number: DYNJ48191G, UPC Number: 019348947660; Model Number: DYNJ48191I, UPC Number: 019532705781; Model Number: DYNJ48191J, UPC Number: 019532725503; Model Number: DYNJ60224B, UPC Number: 019348987735. s. Model Number: DYNJ0378388P, UPC Number: 019532708997. t. Model Number: DYNJ906823A, UPC Number: 019348989447; Model Number: DYNJ906823B, UPC Number: 019532702707. u. Model Number: DYNJ82660, UPC Number: 019532719933. v. Model Number: DYNJ82659, UPC Number: 019532719932. w. Model Number: DYNJ0991320L, UPC Number: 019532702854. x. Model Number: CDS983996B, UPC Number: 088994213130. y. Model Number: DYNJ82736, UPC Number: 019532720755. z. Model Number: DYNJ44483B, UPC Number: 088994281894. aa. Model Number: DYNJ83286, UPC Number: 019532725665. bb. Model Number: DYNJ0271254O, UPC Number: 019348956435; Model Number: DYNJ20495I, UPC Number: 019348956435; Model Number: DYNJ42833A, UPC Number: 088827750399; Model Number: DYNJ42833B, UPC Number: 019348988033; Model Number: PHS656679003, UPC Number: 088994204000. cc. Model Number: DYNJ44484D, UPC Number: 088994281895; Model Number: DYNJ44484F, UPC Number: 019348948834. dd. Model Number: DYNJ908264, UPC Number: 019532702011. ee. Model Number: DYNJ905004A, UPC Number: 088994291171, Model Number: DYNJ908890, UPC Number: 019532720339. ff. Model Number: DYNJ905002B, UPC Number: 019532731686, Model Number: DYNJ908892, UPC Number: 019532720403. gg. Model Number: DYNJ84305, UPC Number: 019532734981. hh. Model Number: DYNJ81727, UPC Number: 019532713711; Model Number: DYNJ81727A, UPC Number: 019532727789. ii. Model Number: DYNJ67367, UPC Number: 019348989571; Model Number: DYNJ67367A, UPC Number: 019532723070. jj. Model Number: DYNJ82758, UPC Number: 019532720744. kk. Model Number: DYNJ908181, UPC Number: 019532700174; Model Number: DYNJ908181A, UPC Number: 019532706226; Model Number: DYNJ908181B, UPC Number: 019532724293. ll. Model Number: DYNJ35262A, UPC Number: 019348990343. mm. Model Number: DYNJ55063, UPC Number: 088994252657. nn. Model Number: DYNJ82393, UPC Number: 019532718973. oo. Model Number: DYNJ57719C, UPC Number: 019348976734; Model Number: DYNJ57719D, UPC Number: 019348994582. pp. Model Number: DYNJ39508A, UPC Number: 088994262891.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 29 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;

Z-2318-2023
Recall number
Z-2318-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
1,182 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ69864A, UPC Number: 019532713205. b. Model Number: DYNJ82257, UPC Number: 019532718165. c. Model Number: DYNJ60224C, UPC Number: 019532715184.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 30 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B; d. AAA PACK, Model Number: DYNJ44918C; e. AAA PACK - TEAM 3, Model Number: DYNJ44847G; f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068; g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A; h. ACCESS KIT, Model Number: DYNDH1159A; i. ACCESS PACK, Model Number: DYNJ69017; j. ACCESSORY KIT, Model Number: DYNJ901348D; k. ADULT CORONARY PACK, Model Number: DYNJV0275F; l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B; m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A; n. AMINO KIT; Model Number: DYNDH1649; o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420; p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q; q. ANGIO TRAY, Model Number: DYNJ23438J; r. ANGIOGRAM PACK, Model Number: DYNJ47004B; s. ANGIOGRAM TRAY, Model Number: DYNJ33638I; t. ANGIO-VASCULAR, Model Number: DYNJ24272B; u. ARTERIAL PACK, Model Number: DYNJ51340D; v. ARTERIO-VENOUS CDS, Model Number: CDS984186C; w. ASPIRATION TRAY, Model Number: DYNDH1467; x. ASPIRE EXACT TRAY, Model Number: DYNJRA1716, DYNJRA1716A; y. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299L; z. BASIC PACK, Model Number: DYNJ37460A, DYNJ42691, DYNJ52122B, DYNJ52171, DYNJ55456, DYNJ55457, DYNJ81343; aa. BASIC PROCEDURE PACK, Model Number: DYNJ53122B; bb. BASIC VEIN PACK, Model Number: DYNJ58650; cc. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; dd. BGMC LIVER TRANSPLANT, Model Number: DYNJ9664651D; ee. BIOPSY TRAY, Model Number: DYNDH1340; ff. BLOCK KIT, Model Number: DYNJRA1145; gg. BLOCK SUPPLIES NDL CNTR, Model Number: DYNJRA1755; hh. BREAST ULTRASOUND PROCEDURE TR, Model Number: DYNDL1596A; ii. BUNDLE KIT, Model Number: DYNJ49737B, DYNJ49737C; jj. C V MAJOR PACK, Model Number: DYNJ64861; kk. CABG UNIVERSITY HOSP PACK-LF, Model Number: DYNJ0375705L; ll. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640; mm. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; nn. CHP TRANSPLANT CDS, Model Number: CDS983082I, CDS983082J; oo. CLINIC PACK, Model Number: DYNJRA1578; pp. CLOSURE CDS, Model Number: CDS983704G, CDS983704I; qq. CLOSURE FAST PACK UNIV, Model Number: DYNJ53482A; rr. CLOSURE PACK, Model Number: DYNJ54437A, DYNJ54437C, DYNJ57514, DYNJ60804; ss. CLOSURE PACK-LF, Model Number: DYNJ0807503M; tt. CLOSURE PROCEDURE, Model Number: DYNJ59206; uu. CLOSURE PROCEDURE PACK, Model Number: DYNJ66741; vv. CLOSURE PROCEDURE PKSJO-LF, Model Number: DYNJ35409F; ww. CLOT RETRIEVAL PACK, Model Number: DYNJ56140B; xx. CLOVIS MINOR IR PROCEDURE-LF, Model Number: DYNJ61067; yy. COMMANDO PACK MSH-LF, Model Number: DYNJ48525D; zz. CONTINUOUS BLOCK, Model Number: DYNJRA0960B; aaa. COPS PROCEDURE PACK-LF, Model Number: DYNJ68923A; bbb. CRMC MINOR IR PROCEDURE PK-LF, Model Number: DYNJ61099, DYNJ61099A; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710; ddd. CV ACCESS PACK WRO-LF, Model Number: DYNJ41875B; eee. CV CDS, Model Number: CDS985395C; fff. CV MINOR CDS, Model Number: CDS984100T; ggg. CV PACK, Model Number: DYNJ45074B; hhh. CVC PACK, Model Number: DYNJ44010; iii. CVL PACK, Model Number: DYNJ00281N; jjj. CVOR CDS-LF, Model Number: CDS840198V; kkk. CYSTO PACK SMGH-LF, Model Number: DYNJ41915A; lll. DAVIES PHALLOPLASTY PACK, Model Number: DYNJ52185F; mmm. DAVINCI, Model Number: DYNJ906543A; nnn. DBD-BASIC PACK, Model Number: DYNJ55458; ooo. DBD-BIOPSY PACK-LF, Model Number: DYNJ0747885F; ppp. DBD-DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069M; qqq. DBD-ECMO MODULE PACK, Model Number: DYNJ55669F; rrr. DBD-EVLA PACK, Model Number: DYNJ6

Z-2319-2023
Recall number
Z-2319-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
83,541 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC4740, UPC Number: 10653160335214. b. Model Number: DYNJ36212C, UPC Number: 088994288566. c. Model Number: DYNJ905651, UPC Number: 088827778831; Model Number: DYNJ905651A, UPC Number: 019348968651; Model Number: DYNJ905651B, UPC Number: 019348992506. d. Model Number: DYNJ44918C, UPC Number: 019348976679. e. Model Number: DYNJ44847G, UPC Number: 019348962983. f. Model Number: DYNJ62540, UPC Number: 019348966647; Model Number: DYNJ64068, UPC Number: 019348978313. g. Model Number: DYNJ53658A, UPC Number: 088994268440. h. Model Number: DYNDH1159A, UPC Number: 088994288165. i. Model Number: DYNJ69017, UPC Number: 019348987815. j. Model Number: DYNJ901348D, UPC Number: 019348959468. k. Model Number: DYNJV0275F, UPC Number: 019348926312. l. Model Number: DYNJ38714B, UPC Number: 088994260193. m. Model Number: DYNJ63576, UPC Number: 019348976954; Model Number: DYNJ63576A, UPC Number: 019348942925. n. Model Number: DYNDH1649, UPC Number: 019348994436. o. Model Number: DYNDH1420, UPC Number: 019348936044. p. Model Number: DYNJ0370436Q, UPC Number: 088827777928. q. Model Number: DYNJ23438J, UPC Number: 019348956435. r. Model Number: DYNJ47004B, UPC Number: 088827775429. s. Model Number: DYNJ33638I, UPC Number: 019348956435. t. Model Number: DYNJ24272B, UPC Number: 019348956435. u. Model Number: DYNJ51340D, UPC Number: 019348956981. v. Model Number: CDS984186C, UPC Number: 088994295750. w. Model Number: DYNDH1467, UPC Number: 019348943966. x. Model Number: DYNJRA1716, UPC Number: 019348926312; Model Number: DYNJRA1716A, UPC Number: 019348989641. y. Model Number: DYNJC9299L, UPC Number: 019348926312. z. Model Number: DYNJ37460A, UPC Number: 088827756043; Model Number: DYNJ42691, UPC Number: 088827700350; Model Number: DYNJ52122B, UPC Number: 019348993530; Model Number: DYNJ52171, UPC Number: 088994224347; Model Number: DYNJ55456, UPC Number: 088994254844; Model Number: DYNJ55457, UPC Number: 088994254846; Model Number: DYNJ81343, UPC Number: 019532711306. aa. Model Number: DYNJ53122B, UPC Number: 019348932122. bb. Model Number: DYNJ58650, UPC Number: 088994287665. cc. Model Number: MNS7695A, UPC Number: 065316034345. dd. Model Number: DYNJ9664651D, UPC Number: 019348939642. ee. Model Number: DYNDH1340, UPC Number: 088994289450. ff. Model Number: DYNJRA1145, UPC Number: 088994292854. gg. Model Number: DYNJRA1755, UPC Number: 019348984284. hh. Model Number: DYNDL1596A, UPC Number: 088438992650. ii. Model Number: DYNJ49737B, UPC Number: 019348939440; Model Number: DYNJ49737C, UPC Number: 019532723588. jj. Model Number: DYNJ64861, UPC Number: 019348922377. kk. Model Number: DYNJ0375705L, UPC Number: 019348954413. ll. Model Number: DYNJ905640, UPC Number: 019348952767. mm. Model Number: TRICHT1120, UPC Number: 065316031829. nn. Model Number: CDS983082I, UPC Number: 088994277286; Model Number: CDS983082J, UPC Number: 019348967451. oo. Model Number: DYNJRA1578, UPC Number: 019348927278. pp. Model Number: CDS983704G, UPC Number: 088994280844; Model Number: CDS983704I, UPC Number: 019348985455. qq. Model Number: DYNJ53482A, UPC Number: 088994291731. rr. Model Number: DYNJ54437A, UPC Number: 088994256796; Model Number: DYNJ54437C, UPC Number: 019348924397; Model Number: DYNJ57514, UPC Number: 088994274784; Model Number: DYNJ60804, UPC Number: 019348953278. ss. Model Number: DYNJ0807503M, UPC Number: 088994209173. tt. Model Number: DYNJ59206, UPC Number: 088827776557. uu. Model Number: DYNJ66741, UPC Number: 019348937494. vv. Model Number: DYNJ35409F, UPC Number: 088827777124. ww. Model Number: DYNJ56140B, UPC Number: 019348954767. xx. Model Number: DYNJ61067, UPC Number: 019348954222. yy. Model Number: DYNJ48525D, UPC Number: 019348975077. zz. Model Number: DYNJRA0960B, UPC Number: 019348926312. aaa. Model Number: DYNJ68923A, UPC Number: 019532707079. bbb. Model Number: DYNJ61099, UPC Number: 019348954424; Model Number: DYNJ61099A, UPC Number: 019348946396. ccc. Model Number: DYNJ65710, UPC Number: 019348928508. ddd. Model Number: DYNJ41875B, UPC Number: 019348956307. eee. Model Number: CDS985395C, UPC Number: 088994286348. fff. Model Number: CDS984100T, UPC Number: 019348939994. ggg. Model Number: DYNJ45074B, UPC Number: 088994284064. hhh. Model Number: DYNJ44010, UPC Number: 088827707945. iii. Model Number: DYNJ00281N, UPC Number: 019348956435. jjj. Model Number: CDS840198V, UPC Number: 088994295567. kkk. Model Number: DYNJ41915A, UPC Number: 088827756881. lll. Model Number: DYNJ52185F, UPC Number: 019348936871. mmm. Model Number: DYNJ906543A, UPC Number: 019348981803. nnn. Model Number: DYNJ55458, UPC Number: 088994254845. ooo. Model Number: DYNJ0747885F, UPC Number: 019348956435. ppp. Model Number: DYNJ0426069M, UPC Number: 019532720575. qqq. Model Number: DYNJ55669F, UPC Number: 019532731371. rrr. Model Number: DYNJ66258A, UPC Number: 019532719423. sss. Model Number: DYNJ66620A, UPC Number: 019348991424. ttt. Model Number: CDS984379D, UPC Number: 088994272434. uuu. Model Number: DYNJ0604540Q, UPC Number: 019348983968. vvv. Model Number: DYNJ38563O, UPC Number: 019348925174. www. Model Number: DYNJ905936B, UPC Number: 019348942281. xxx. Model Number: DYNJ906902A, UPC Number: 019348997120. yyy. Model Number: DYNJ900337A, UPC Number: 088994219386. zzz. Model Number: DYNJ58160, UPC Number: 088994282864. aaaa. Model Number: DYNDA2769, UPC Number: 019348945716. bbbb. Model Number: DYNJ68923, UPC Number: 019348985856. cccc. Model Number: CDS984329J, UPC Number: 088994286535. dddd. Model Number: CDS984327I, UPC Number: 088994286537. eeee. Model Number: DYNJ33546K, UPC Number: 019348991717. ffff. Model Number: DYNJ908752, UPC Number: 019532717136. gggg. Model Number: DYNJ53845A, UPC Number: 088994253675. hhhh. Model Number: DYNJ68959, UPC Number: 019348986686. iiii. Model Number: DYNJ48454, UPC Number: 088827759528. jjjj. Model Number: DYNJ60128A, UPC Number: 019348954451. kkkk. Model Number: DYNJ907279, UPC Number: 019348938641. llll. Model Number: DYNJ31934D, UPC Number: 019532707150. mmmm. Model Number: DYNDA2011B, UPC Number: 019348953302. nnnn. Model Number: DYNJ59377, UPC Number: 088827773629. oooo. Model Number: DYNJRA0585, UPC Number: 088827758069. pppp. Model Number: DYNJ83438, UPC Number: 019532726659. qqqq. Model Number: DYNJ35457B, UPC Number: 019348956435. rrrr. Model Number: DYNJ905702B, UPC Number: 019348958721. ssss. Model Number: DYNJ66867, UPC Number: 019348939016. tttt. Model Number: DYNJ60669A, UPC Number: 019348920588; Model Number: DYNJ60669B, UPC Number: 019348987734; Model Number: DYNJ63156A, UPC Number: 019348985231; Model Number: DYNJ64964A, UPC Number: 019348935382. uuuu. Model Number: DYNJ82575, UPC Number: 019532719811. vvvv. Model Number: DYNJ0426069M, UPC Number: 019532720575. wwww. Model Number: DYNJRA1226A, UPC Number: 019348956964. xxxx. Model Number: DYNJ66283A, UPC Number: 019348940904. yyyy. Model Number: DYNJ907552, UPC Number: 019348949583. zzzz. Model Number: DYNJ0351069, UPC Number: 088994205905.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 31 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,

Z-2320-2023
Recall number
Z-2320-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
93,587 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ67517, UPC Number: 019348940782. b. Model Number: DYNJ51416B, UPC Number: 088827774647. c. Model Number: DYNJ42913, UPC Number: 088827701320; Model Number: DYNJ42913A, UPC Number: 019532708060. d. Model Number: DYNJ61243, UPC Number: 019348955091. e. Model Number: DYNJ66291, UPC Number: 019348932808, Model Number: DYNJ66291A, UPC Number: 019348948000. f. Model Number: DYNJ57449A, UPC Number: 088994282753. g. Model Number: DYNJ26940G, UPC Number: 019348954079. h. Model Number: DYNJ60126, UPC Number: 088994295193. i. Model Number: DYNJ54265, UPC Number: 088994247400. j. Model Number: DYNJ59085, UPC Number: 088994293201. k. Model Number: DYNJ42831D, UPC Number: 088994284953. l. Model Number: DYNJ53435C, UPC Number: 019348920086. m. Model Number: DYNJ48456B, UPC Number: 088994273317. n. Model Number: DYNJ59168, UPC Number: 088827776444. o. Model Number: DYNJ58228, UPC Number: 088994283549. p. Model Number: DYNJ62443, UPC Number: 019348967919. q. Model Number: DYNJ59392C, UPC Number: 019348928224. r. Model Number: DYNJ907013, UPC Number: 019348931863. s. Model Number: DYNJ57594A, UPC Number: 088994296321. t. Model Number: DYNJ900005L, UPC Number: 019348930031. u. Model Number: DYNJ66258, UPC Number: 019348932547. v. Model Number: DYNJ62417, UPC Number: 019348965705; Model Number: DYNJ64336, UPC Number: 019348980187. w. Model Number: DYNJ45294, UPC Number: 088827709897. x. Model Number: DYNJ38674A, UPC Number: 019348956435; Model Number: DYNJ45997C, UPC Number: 088994268436; Model Number: DYNJ56548B, UPC Number: 019348981318; Model Number: DYNJ65995, UPC Number: 019348931154; Model Number: DYNJ65995A, UPC Number: 019532706812; Model Number: DYNJ66005, UPC Number: 019348931254. y. Model Number: DYNJ01964M, UPC Number: 019348956435; Model Number: DYNJ67487A, UPC Number: 019348988899. z. Model Number: DYNJ904069C, UPC Number: 019348999549. aa. Model Number: DYNJ58572B, UPC Number: 019348989338; Model Number: DYNJ58572C, UPC Number: 019532714262. bb. Model Number: DYNJ59657A, UPC Number: 019348954461. cc. Model Number: DYNJ905146A, UPC Number: 019348956922. dd. Model Number: DYNJ68380C, UPC Number: 019532734124. ee. Model Number: DYNJ0271254P, UPC Number: 019532708953. ff. Model Number: DYNJ82179, UPC Number: 019532718266. gg. Model Number: DYNJZ45357, UPC Number: 088994237354. hh. Model Number: DYNJ41137B, UPC Number: 088994226087. ii. Model Number: DYNJ0972464Y, UPC Number: 019348978326. jj. Model Number: DYNJ906579C, UPC Number: 019532702356. kk. Model Number: DYNJ59500, UPC Number: 088827775013. ll. Model Number: DYNJ59501, UPC Number: 088827775014. mm. Model Number: DYNJ59508, UPC Number: 088827775130. nn. Model Number: DYNJ69204B, UPC Number: 019532736422. oo. Model Number: DYNJ40374A, UPC Number: 088827755794. pp. Model Number: DYNJ905335, UPC Number: 088994287589. qq. Model Number: SYNJ10303B, UPC Number: 019348937374. rr. Model Number: DYNJ60343A, UPC Number: 019348957383. ss. Model Number: DYNJ9048708F, UPC Number: 019348972521. tt. Model Number: DYNJ44519F, UPC Number: 019348946747. uu. Model Number: DYNJ39198I, UPC Number: 019348956435. vv. Model Number: DYNJ45033A, UPC Number: 019348947580. ww. Model Number: DYNDA2365, UPC Number: 019348951634; Model Number: DYNDA2365B, UPC Number: 019348983644. xx. Model Number: DYNJ69820, UPC Number: 019348998143. yy. Model Number: DYNJ51927A, UPC Number: 088827779416. zz. Model Number: DYNJ0530948AR, UPC Number: 019532714188; Model Number: DYNJ0586030P, UPC Number: 088994294714. aaa. Model Number: DYNJ66065, UPC Number: 019348931918. bbb. Model Number: DYNJ57547, UPC Number: 088994275104; Model Number: DYNJ58647, UPC Number: 088994287545; Model Number: DYNJ60127A, UPC Number: 019348972904. ccc. Model Number: DYNJ69619, UPC Number: 019348995944. ddd. Model Number: DYNJ903873C, UPC Number: 019348946309. eee. Model Number: DYNJ905682, UPC Number: 088827779190. fff. Model Number: DYKMBNDL173B, UPC Number: 019532724075. ggg. Model Number: DYNJ902261D, UPC Number: 088994275524; Model Number: DYNJ904401B, UPC Number: 019348968343. hhh. Model Number: DYNJ56283B, UPC Number: 019348969525. iii. Model Number: DYNJ35524D, UPC Number: 019348976610. jjj. Model Number: DYNJ80299, UPC Number: 019532702193. kkk. Model Number: DYNJ64075A, UPC Number: 019348923132. lll. Model Number: DYNJ39053A, UPC Number: 019348956435. mmm. Model Number: DYNJ47987B, UPC Number: 019348986737. nnn. Model Number: DYNJ0931376F, UPC Number: 019348927150. ooo. Model Number: DYNJ905655, UPC Number: 088827778885; Model Number: DYNJ905655B, UPC Number: 019532713015. ppp. Model Number: CDS984951D, UPC Number: 019348925779. qqq. Model Number: DYNJ0271349T, UPC Number: 019532708969. rrr. Model Number: DYNJ83152, UPC Number: 019532723708. sss. Model Number: DYNJ902168D, UPC Number: 019348986615. ttt. Model Number: CDS982911M, UPC Number: 019348946493. uuu. Model Number: DYNJ68172, UPC Number: 019348949239. vvv. Model Number: CDS980752I, UPC Number: 088994242854; Model Number: DYNJ54285A, UPC Number: 088994276548. www. Model Number: CDS983315G, UPC Number: 088994286443. xxx. Model Number: DYND2673B, UPC Number: 019348956435. yyy. Model Number: DYNJ51705B, UPC Number: 019348987717. zzz. Model Number: DYNJ0248546C, UPC Number: 088994205551; Model Number: DYNJ0248546D, UPC Number: 019532706928. aaaa. Model Number: CDS984379D, UPC Number: 088994272434. bbbb. Model Number: MID0001, UPC Number: 019348938162. cccc. Model Number: DYNJ80141MB, UPC Number: 088994273341. dddd. Model Number: PICC0009A, UPC Number: 088994214185. eeee. Model Number: DYNJ80152MB, UPC Number: 088994273342. ffff. Model Number: DYNJ905002A, UPC Number: 088994291165. gggg. Model Number: DYNJ64439, UPC Number: 019348920048. hhhh. Model Number: DYNJ38326F, UPC Number: 019348956435. iiii. Model Number: DYNJ902281, UPC Number: 088827798141. jjjj. Model Number: NG410A, UPC Number: 088994294588. kkkk. Model Number: DYNJ63892, UPC Number: 019348977143. llll. Model Number: DYNJ69716A, UPC Number: 019532725057. mmmm. Model Number: ARTNC115, UPC Number: 065316035433. nnnn. Model Number: DYNJ63739, UPC Number: 019348975467. oooo. Model Number: DYNJ59201B, UPC Number: 019348931026; Model Number: DYNJ59201C, UPC Number: 019532706202. pppp. Model Number: DYNJ908680, UPC Number: 019532713938. qqqq. Model Number: DYNJ61517, UPC Number: 019348957757. rrrr. Model Number: DYNJ82561, UPC Number: 019532719797. ssss. Model Number: DYNJ54569A, UPC Number: 019348974295. tttt. Model Number: DYNJ60126A, UPC Number: 019348924708. uuuu. Model Number: DYNJ65488B, UPC Number: 019348944364. vvvv. Model Number: DYNJ906902, UPC Number: 019348928093. wwww. Model Number: DYNJ906895C, UPC Number: 019532730355. xxxx. Model Number: DYNDH1165A, UPC Number: 088994261150, 10889942611508. yyyy. Model Number: DYNJ37280C, UPC Number: 088994243165; Model Number: DYNJ56536, UPC Number: 088994265471. zzzz. Model Number: DYNDH1292, UPC Number: 088994274223; Model Number: DYNDH1470B, UPC Number: 019348911124; Model Number: DYNDH1470C, UPC Number: 019532729771.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 32 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D; e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747; f. PERIPHERAL PACK, Model Number: DYNJ44960D; g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865; h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B; i. PERMACATH-LF, Model Number: DYNJ42262D; j. PHLEBECTOMY PACK, Model Number: DYNJ47502B; k. PHYSIATRY PACK, Model Number: DYNJ67414; l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A; m. PICC INSERTION PACK, Model Number: DYNJ60038; n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F; o. PICC LINE INSERTION, Model Number: DYNJ39885A; p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B; q. PICC LINE TRAY, Model Number: DYNJ52688A; r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F; s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717; t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990; u. PICC PROCEDURE PACK, Model Number: DYNJ59067; v. PICC TRAY, Model Number: DYNJ49177F; w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; x. PK GEN-RECIPIENT, Model Number: DYNJ41114C; y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A; z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A; aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A; bb. PORT INSERTION PACK, Model Number: CVI4765; cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990; dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C; ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393; ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B; gg. PREP TRAY, Model Number: DYNJRA1498; hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968; ii. PUH AV FISTULA CDS, Model Number: CDS984329J; jj. PURPLE PACK, Model Number: DYNJ62197; kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F; ll. PV PACK, Model Number: DYNJ46549J; mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131; nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B; oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A; pp. RADIOLOGY PACK, Model Number: DYNJ42172A; qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B; rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M; ss. RADIOLOGY TRAY, Model Number: MNS11625; tt. RECIPIENT PACK, Model Number: DYNJ41114B; uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256; vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899; ww. RIGHT HEART TRAY, Model Number: DYNJ40379C; xx. ROBOT, Model Number: DYNJ906112; yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A; zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F; aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J; bbb. RR-SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O; ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A; ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M; eee. SMH VASCULAR CDS, Model Number: CDS984584L; fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C; ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y; hhh. SPECIALS PACK, Model Number: DYNJ67504A; iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B; jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027; kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J; lll. STERILE INJECTION PACK, Model Number: DYNDA2805; mmm. SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958; nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C; ooo. SVMMC VASCULAR MAJOR PA

Z-2321-2023
Recall number
Z-2321-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
233,638 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ54755B, UPC Number: 088994292536. b. Model Number: DYNJ40306A, UPC Number: 088994260192. c. Model Number: DYNJ0774759P, UPC Number: 019532724613. d. Model Number: DYNJ902261D, UPC Number: 088994275524. e. Model Number: DYNJRA1747, UPC Number: 019348946400. f. Model Number: DYNJ44960D, UPC Number: 019348983324. g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443. h. Model Number: DYNJ904401B, UPC Number: 019348968343. i. Model Number: DYNJ42262D, UPC Number: 088994269795. j. Model Number: DYNJ47502B, UPC Number: 019348964922. k. Model Number: DYNJ67414, UPC Number: 019348996464. l. Model Number: PHS41739A, UPC Number: 088994290680. m. Model Number: DYNJ60038, UPC Number: 088827779327. n. Model Number: CDS982858F, UPC Number: 088827773921. o. Model Number: DYNJ39885A, UPC Number: 088994253993. p. Model Number: DYNJ41873B, UPC Number: 019348956306. q. Model Number: DYNJ52688A, UPC Number: 088994284356. r. Model Number: CDS982859F, UPC Number: 088827773920. s. Model Number: DYNJ47717, UPC Number: 088827751458. t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847. u. Model Number: DYNJ59067, UPC Number: 088994293004. v. Model Number: DYNJ49177F, UPC Number: 088827777434. w. Model Number: DYNDC2399A, UPC Number: 088994244693. x. Model Number: DYNJ41114C, UPC Number: 019532726173. y. Model Number: DYNJ54894A, UPC Number: 019348921355. z. Model Number: DYNJ54894A, UPC Number: 019348921355. aa. Model Number: DYNJ54982A, UPC Number: 019348980895. bb. Model Number: CVI4765, UPC Number: 019348995318. cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261. dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176. ee. Model Number: DYNJ64393, UPC Number: 019348980963. ff. Model Number: DYNJRA1155B, UPC Number: 019348958371; Model Number: DYNJRA1200B, UPC Number: 019348956827. gg. Model Number: DYNJRA1498, UPC Number: 019348979574. hh. Model Number: DYNJ55063A, UPC Number: 019348968054; Model Number: DYNJ57674A, UPC Number: 088827777174; Model Number: DYNJ59795A, UPC Number: 019348956698; Model Number: DYNJ62588, UPC Number: 019348966983; Model Number: DYNJ64372, UPC Number: 019348980722; Model Number: DYNJ64372A, UPC Number: 019348988468; Model Number: DYNJ68968, UPC Number: 019348987039. ii. Model Number: CDS984329J, UPC Number: 088994286535. jj. Model Number: DYNJ62197, UPC Number: 019348963300. kk. Model Number: DYNJ45757F, UPC Number: 088827779258. ll. Model Number: DYNJ46549J, UPC Number: 019348933778. mm. Model Number: DYNJ35574A, UPC Number: 088438953806; Model Number: DYNJ54131, UPC Number: 088994246680. nn. Model Number: DYNJ60698B, UPC Number: 019532706789. oo. Model Number: DYNJ63155A, UPC Number: 019348931402. pp. Model Number: DYNJ42172A, UPC Number: 019348950271. qq. Model Number: DYNJ58225B, UPC Number: 088827777898. rr. Model Number: PHS479840M, UPC Number: 019348968272. ss. Model Number: MNS11625, UPC Number: 065316032213. tt. Model Number: DYNJ41114B, UPC Number: 088994269269. uu. Model Number: DYNJRA1256, UPC Number: 019348951155. vv. Model Number: DYNJ57149, UPC Number: 088994272160; Model Number: DYNJ67899, UPC Number: 019348945449. ww. Model Number: DYNJ40379C, UPC Number: 088994281455. xx. Model Number: DYNJ906112, UPC Number: 019348965663. yy. Model Number: DYNJ60009A, UPC Number: 019348964887. zz. Model Number: DYNJ905826B, UPC Number: 019348978095; Model Number: DYNJ905826C, UPC Number: 019348940758; Model Number: DYNJ905826D, UPC Number: 019532702352; Model Number: DYNJ905826F, UPC Number: 019532721705. aaa. Model Number: DYNJ33546J, UPC Number: 019348956435. bbb. Model Number: DYNJ0785821M, UPC Number: 019348956435; Model Number: DYNJ0785821N, UPC Number: 019348956435; Model Number: DYNJ0785821O, UPC Number: 019532726373. ccc. Model Number: DYNJ62434A, UPC Number: 019348936627. ddd. Model Number: DYNJ0369434M, UPC Number: 019532729542. eee. Model Number: CDS984584L, UPC Number: 088994270130. fff. Model Number: DYNJ53135B, UPC Number: 019348966082; Model Number: DYNJ53135C, UPC Number: 019348946843. ggg. Model Number: DYNJ0416535U, UPC Number: 019348956435; Model Number: DYNJ0416535Y, UPC Number: 019348956435. hhh. Model Number: DYNJ67504A, UPC Number: 019532700961. iii. Model Number: DYNJ57303A, UPC Number: 088827778321; Model Number: DYNJ57303B, UPC Number: 019348936064. jjj. Model Number: DYNJ64027, UPC Number: 019348977993. kkk. Model Number: DYNJ49833J, UPC Number: 019532705946. lll. Model Number: DYNDA2805, UPC Number: 019348984614. mmm. Model Number: DYNJRA0958, UPC Number: 088994261890. nnn. Model Number: DYNJ48153C, UPC Number: 088994276562. ooo. Model Number: DYNJ43777G, UPC Number: 088994291573. ppp. Model Number: DYNJ63339A, UPC Number: 019348929531; Model Number: DYNJ63339B, UPC Number: 019348984061. qqq. Model Number: DYNJ53319C, UPC Number: 019348963449. rrr. Model Number: DYNJ63340, UPC Number: 019348974116. sss. Model Number: DYNJ906391B, UPC Number: 019348981688. ttt. Model Number: DYNDH1190, UPC Number: 088994249424. uuu. Model Number: DYKM2125, UPC Number: 019532704487. vvv. Model Number: DYNJ58424, UPC Number: 088994285183. www. Model Number: DYNJ37099C, UPC Number: 019348956435. xxx. Model Number: DYNJ59062, UPC Number: 088994294165. yyy. Model Number: TVS4300A, UPC Number: 081698202335. zzz. Model Number: TVS4500A, UPC Number: 081698202337; Model Number: TVS4500B, UPC Number: 019532722356. aaaa. Model Number: ULT2175B, UPC Number: 019348958303; Model Number: ULT2175C, UPC Number: 10653160344353. bbbb. Model Number: DYNDV2537, UPC Number: 019532718408. cccc. Model Number: DYNDC2099, UPC Number: 088827729567. dddd. Model Number: DYNJ56535, UPC Number: 088994265334. eeee. Model Number: DYNDH1319, UPC Number: 088994279547. ffff. Model Number: DYNDV2385A, UPC Number: 019532729876. gggg. Model Number: IVS3485A, UPC Number: 065316099015; Model Number: IVS3840A, UPC Number: 019348947673. hhhh. Model Number: DYNDV2038B, UPC Number: 019348991983; Model Number: IVS3300, UPC Number: 065316030766; Model Number: IVS3495A, UPC Number: 065316099305. iiii. Model Number: IVS3820, UPC Number: 065316034231. jjjj. Model Number: DYNDV2371, UPC Number: 019348943086. kkkk. Model Number: DYNJ56507B, UPC Number: 019348944347; Model Number: DYNJ64930, UPC Number: 019348923168. llll. Model Number: DYNDH1112, UPC Number: 10889942277360. mmmm. Model Number: IV8635D, UPC Number: 065316099026. nnnn. Model Number: DYNDV2502, UPC Number: 019532701409. oooo. Model Number: DYNDH1204, UPC Number: 088994251983; Model Number: DYNDH1468A, UPC Number: 019348944003; Model Number: DYNJRA0389, UPC Number: 088438972552; Model Number: DYNDH1204, UPC Number: 10889942519835. pppp. Model Number: DYNJ61433, UPC Number: 019348956517. qqqq. Model Number: DYNJ60006A, UPC Number: 019348981007. rrrr. Model Number: DYNJ51638B, UPC Number: 019348994641; Model Number: DYNJ51638C, UPC Number: 019532703956. ssss. Model Number: DYNDH1492, UPC Number: 019348943446. tttt. Model Number: DYNJ904401B, UPC Number: 019348968343. uuuu. Model Number: DYNJ902259A, UPC Number: 088994225654. vvvv. Model Number: CDS982895I, UPC Number: 088994220768. wwww. Model Number: DYNJ902261D, UPC Number: 088994275524. xxxx. Model Number: DYNJ43593A, UPC Number: 088994225559; Model Number: DYNJ53475D, UPC Number: 019348954775. yyyy. Model Number: VC-PK, UPC Number: 019532717689. zzzz. Model Number: DYNJ63268B, UPC Number: 019348930511; Model Number: DYNJ66079, UPC Number: 019348931744. aaaaa. Model Number: DYNJ61148A, UPC Number: 019348954925. bbbbb. Model Number: DYNJ32397B, UPC Number: 088438991665; Model Number: DYNJ54139A, UPC Number: 088994256499; Model Number: DYNJ59094, UPC Number: 088994293350; Model Number: DYNJ65189C, UPC Number: 019532707200. ccccc. Model Number: DYNJS3005, UPC Number: 088438909956. ddddd. Model Number: DYNJ55841B, UPC Number: 088827775768. eeeee. Model Number: DYNJ64190A, UPC Number: 019348943563. fffff. Model Number: DYNJ0309084D, UPC Number: 088994288526; Model Number: DYNJ38682C, UPC Number: 088994289719; Model Number: DYNJ51248B, UPC Number: 088994287340; Model Number: DYNJ59662A, UPC Number: 019348954814; Model Number: DYNJ59681, UPC Number: 088827777552; Model Number: DYNJ61264, UPC Number: 019348955447. ggggg. Model Number: DYNJ59631, UPC Number: 088827776402. hhhhh. Model Number: DYNDA2076, UPC Number: 088994270850. iiiii. Model Number: DYNJ38264C, UPC Number: 019348956435. jjjjj. Model Number: DYNJ57736A, UPC Number: 088827777970. kkkkk. Model Number: DYNJ59751A, UPC Number: 019348959856. lllll. Model Number: DYNJ20094J, UPC Number: 019348956435; Model Number: DYNJ20094K, UPC Number: 019348956435. mmmmm. Model Number: DYNJ56260B, UPC Number: 019348956982. nnnnn. Model Number: DYNJ64666A, UPC Number: 019348931726. ooooo. Model Number: DYNJ901392D, UPC Number: 019348953951. ppppp. Model Number: DYNJ59246, UPC Number: 088827776729. qqqqq. Model Number: DYNJ53349A, UPC Number: 088994257453. rrrrr. Model Number: DYNJ35988G, UPC Number: 019348956435; Model Number: DYNJ35988I, UPC Number: 019348956435; Model Number: DYNJ35988J, UPC Number: 019532702466. sssss. Model Number: DYNJ56392, UPC Number: 088994264067; Model Number: DYNJ56392A, UPC Number: 019532726140.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 33 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ART LINE TRAY, Model Number: ART865; k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560; l. ARTERIAL LINE TRAY, Model Number: ART840; m. ARTHROGRAM TRAY, Model Number: SPEC0232; n. BASIC BIOPSY TRAY, Model Number: DYNDH1534; o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065; p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; q. BIOPSY TRAY, Model Number: DYNDH1661, MNS8705; r. BIOPSY/ASPIRATION TRAY, Model Number: BT235A; s. BRST BX Tray, Model Number: DYNDH1389A; t. CATHETER PREP KIT, Model Number: DYNDC2638, DYNDC2638A; u. CENTRAL LINE INSERTION KIT, Model Number: DT15975; v. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; w. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; x. CONTINUOUS NERVE BLOCK PREP KIT, Model Number: MNS6660; y. CVC ACCESSORY BUNDLE, Model Number: CVI4505; z. CVC INFANT INSERTION PACK, Model Number: CVI4770; aa. CVC INSERTION BUNDLE, Model Number: CVI3940; bb. CVC INSERTION BUNDLE- ADD A CATHETER, Model Number: CVI4905; cc. CVL INSERTION TRAY, Model Number: DYNDC1786A; dd. DIAGNOSTIC PROCEDURE TRAY, Model Number: DYNJRA0585; ee. DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4050; ff. DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number: CVI4655; gg. EXTREMITY PACK, Model Number: CVI4680; hh. FEMORAL ARTERIAL LINE BUNDLE, Model Number: ART1005; ii. FEMORAL ARTERIAL LINE TRAY, Model Number: ART945; jj. FISHLINE KIT, Model Number: CVI4725; kk. FNA TRAY, Model Number: DYNDH1123B; ll. GENERAL ASPIRATION TRAY - CHOICE, Model Number: DYNDH1397; mm. HEMODIALYSIS ACCESS KIT, Model Number: DT12970; nn. IMPLANT ACCESSORY PACK, Model Number: MNS12955; oo. MAX BARRIER ART LINE KIT, Model Number: ART950; pp. MAX BARRIER KIT, Model Number: DYND2673B; qq. MIDLINE INSERTION, Model Number: DYNDC2890; rr. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; ss. MULTI-PURPOSE SPECIALS TRAY, Model Number: MNS8565; tt. MVHS CVC LUMEN TRAY, Model Number: CVI4920; uu. NECK BIOPSY KIT, Model Number: DYNDH1449A; vv. NERVE BLOCK TRAY, Model Number: MNS8315; ww. PARA/THORACENTESIS TRAY, Model Number: DYNDH1292, DYNDH1470, DYNDH1470A, DYNDH1470B; xx. PEDI ULTRASOUND GUIDED PIV KIT, Model Number: IVS3320; yy. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450A; zz. PEDIATRIC ULTRASOUND KIT, Model Number: MNS12995A; aaa. PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; bbb. PERM CATH KIT, Model Number: MNS10755; ccc. PICC INSERTION BUNDLE, Model Number: CVI3830, CVI4025, CVI4025A; ddd. PICC INSERTION BUNDLE (P/S), Model Number: CVI4025; eee. PICC INSERTION KIT, Model Number: CVI3735, CVI4615; fff. PICC SUPPLEMENTAL KIT, Model Number: DYNDC2373A; ggg. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; hhh. PORT INSERTION KIT, Model Number: MNS11590; iii. PPE BUNDLE KIT, Model Number: DT13351A; jjj. RADIOLOGY TRAY, Model Number: MNS11625; kkk. SCLEROTHERAPY KIT, Model Number: DYNDA2148A; lll. THYROID BIOPSY TRAY-CHOICE, Model Number: DYNDA2446; mmm. THYROID FNA TRAY, Model Number: DYNDA2238, DNDA2238A. nnn. TOTE MCADAMS OSC SHLDR ARTHRO, Model Number: DYKM1790A; ooo. TREATMENT PACK, Model Number: TPO71922-3; ppp. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; qqq

Z-2322-2023
Recall number
Z-2322-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
134,514 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ART960, UPC Number: 10193489190915. b. Model Number: ART970, UPC Number: 10193489190922. c. Model Number: ART1165, UPC Number: 10653160354680. d. Model Number: ART240A, UPC Number: 10653160328025. e. Model Number: ART245A, UPC Number: 10653160328018; Model Number: ART245B, UPC Number: 10653160358442. f. Model Number: ART690, UPC Number: 10653160318019. g. Model Number: ART645, UPC Number: 10653160314394. h. Model Number: MNS8750, UPC Number: 065316027073. i. Model Number: DT22570A, UPC Number: 10653160346074. j. Model Number: ART865, UPC Number: 10653160325062. k. Model Number: ART255, UPC Number: 10653160311997; Model Number: ART560, UPC Number: 10653160310822. l. Model Number: ART840, UPC Number: 10653160322924. m. Model Number: SPEC0232, UPC Number: 10888277507418. n. Model Number: DYNDH1534, UPC Number: 10193489197082. o. Model Number: MNS12065, UPC Number: 10653160331193. p. Model Number: MNS7695A, UPC Number: 10653160343455. q. Model Number: DYNDH1661, UPC Number: 10193489111521; Model Number: MNS8705, UPC Number: 10653160267508. r. Model Number: BT235A, UPC Number: 10653160315919. s. Model Number: DYNDH1389A, UPC Number: 10193489193510. t. Model Number: DYNDC2638, UPC Number: 10889942786428; Model Number: DYNDC2638A, UPC Number: 10193489782813. u. Model Number: DT15975, UPC Number: 065316025244. v. Model Number: DT22260, UPC Number: 10653160329190. w. Model Number: TRICHT1120, UPC Number: 10653160318293. x. Model Number: MNS6660, UPC Number: 00653160223477. y. Model Number: CVI4505, UPC Number: 10653160319047. z. Model Number: CVI4770, UPC Number: 10193489111262. aa. Model Number: CVI3940, UPC Number: 065316027297. bb. Model Number: CVI4905, UPC Number: 10653160355618. cc. Model Number: DYNDC1786A, UPC Number: 10193489199116. dd. Model Number: DYNJRA0585, UPC Number: 10888277580695. ee. Model Number: CVI4050, UPC Number: 10653160278894. ff. Model Number: CVI4655, UPC Number: 10193489190373. gg. Model Number: CVI4680, UPC Number: 10193489198492. hh. Model Number: ART1005, UPC Number: 10193489198232. ii. Model Number: ART945, UPC Number: 10653160330165. jj. Model Number: CVI4725, UPC Number: 10193489199871. kk. Model Number: DYNDH1123B, UPC Number: 10193489193312. ll. Model Number: DYNDH1397, UPC Number: 10888277733206. mm. Model Number: DT12970, UPC Number: 00653160223712. nn. Model Number: MNS12955, UPC Number: 10653160344681. oo. Model Number: ART950, UPC Number: 10653160330226. pp. Model Number: DYND2673B, UPC Number: 10193489191394. qq. Model Number: DYNDC2890, UPC Number: 10193489784213. rr. Model Number: DYNDA2418, UPC Number: 10888277732698. ss. Model Number: MNS8565, UPC Number: 10653160264927. tt. Model Number: CVI4920, UPC Number: 10653160355847. uu. Model Number: DYNDH1449A, UPC Number: 10193489193701. vv. Model Number: MNS8315, UPC Number: 10653160259916. ww. Model Number: DYNDH1292, UPC Number: 10889942742233; Model Number: DYNDH1470, UPC Number: 10193489193787; Model Number: DYNDH1470A, UPC Number: 10193489196818; Model Number: DYNDH1470B, UPC Number: 10193489111248. xx. Model Number: IVS3320, UPC Number: 10653160308300. yy. Model Number: CVI4450A, UPC Number: 10653160320517. zz. Model Number: MNS12995A, UPC Number: 10653160356592. aaa. Model Number: CHT1825, UPC Number: 10653160328988. bbb. Model Number: MNS10755, UPC Number: 10653160314431. ccc. Model Number: CVI3830, UPC Number: 10653160269946; Model Number: CVI4025, UPC Number: 10653160279792; Model Number: CVI4025A, UPC Number: 10193489396058. ddd. Model Number: CVI4025, UPC Number: 10653160279792. eee. Model Number: CVI3735, UPC Number: 10653160261544; Model Number: CVI4615, UPC Number: 10653160327011. fff. Model Number: DYNDC2373A, UPC Number: 10889942492206. ggg. Model Number: DYNDC2399A, UPC Number: 10889942446933. hhh. Model Number: MNS11590, UPC Number: 10653160321293. iii. Model Number: DT13351A, UPC Number: 065316032558. jjj. Model Number: MNS11625, UPC Number: 10653160322139. kkk. Model Number: DYNDA2148A, UPC Number: 10888277734036. lll. Model Number: DYNDA2446, UPC Number: 10888277733121. mmm. Model Number: DYNDA2238, UPC Number: 10888277734173; Model Number: DYNDA2238A, UPC Number: 10193489191554. nnn. Model Number: DYKM1790A, UPC Number: 10193489112412. ooo. Model Number: TPO71922-3, UPC Number: 00860000300636. ppp. Model Number: DYNDH1121C, UPC Number: 10193489193299. qqq. Model Number: MNS2845, UPC Number: 065316006110. rrr. Model Number: IVS3635A, UPC Number: 10193489782011. sss. Model Number: SPEC0291B, UPC Number: 10889942453054. ttt. Model Number: DYNDC2099, UPC Number: 10888277295674. uuu. Model Number: DYNDH1542, UPC Number: 10193489197396. vvv. Model Number: DYNDV2340, UPC Number: 10193489194937. www. Model Number: DYNDV2038A, UPC Number: 10889942784059; Model Number: IVS3505A, UPC Number: 10653160329602; Model Number: MNS9580, UPC Number: 10653160287049; Model Number: IVS3610, UPC Number: 10653160322856. xxx. Model Number: DYNJ0182378A, UPC Number: 10653160328254; Model Number: DYNJ0182378B, UPC Number: 10653160338536. yyy. Model Number: DYNDV2073A, UPC Number: 10889942780198. zzz. Model Number: CVI4430, UPC Number: 10653160314370. aaaa. Model Number: CVI4325, UPC Number: 10653160307037. bbbb. Model Number: DYNDH1492, UPC Number: 10193489193909. cccc. Model Number: DYNDH1652, UPC Number: 10193489111033. dddd. Model Number: DYNDV2536A, UPC Number: 10653160357872. eeee. Model Number: CVI4180, UPC Number: 10653160284451. ffff. Model Number: CVI4265, UPC Number: 10653160291268. gggg. Model Number: DYNDA2076, UPC Number: 10889942708505. hhhh. Model Number: CVI4830A, UPC Number: 10653160353553; Model Number: CVI4830B, UPC Number: 10653160358534. iiii. Model Number: ART685, UPC Number: 10653160314592.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 34 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810; d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915; e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770; f. IV SECUREMENT KIT, Model Number: DYNDV2407A; g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005; h. MIDLINE INSERTION TRAY, Model Number: CVI4340; i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011; j. MIDLINE KIT 4F SL MB, Model Number: MID0001; k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003; l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A; m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB; n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765; o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B; p. NICU PICC TRAY, Model Number: CVI3740A; q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990; r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B; s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865; t. PICC BUNDLE 5FR DL, Model Number: PICC0013; u. PICC INSERTION BUNDLE, Model Number: DT14560; v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820; w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012; x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; y. PIV BSI KIT, Model Number: BSIPIV1010; z. PIV KIT, Model Number: BSIPIV1004; aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A; bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700; cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A; dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350; ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547; ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006; gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385; hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075; ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011; jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B; kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005; ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715; mm. ULTRASOUND IV START KIT, Model Number: IV8790; nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C; oo. ULTRASOUND PIV KIT, Model Number: IVS3970; pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910; qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125; rr. USG IV START KIT, Model Number: DYNDV2435; ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567; tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01; uu. USGPIV KIT, Model Number: DYNDV2578; vv. USPIV KIT, Model Number: IVS3910; ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880; xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A; yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A; zz. VI PACK, Model Number: DYNJ64871

Z-2323-2023
Recall number
Z-2323-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
218,163 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNDA2482, UPC Number: 10193489198188. b. Model Number: ART920, UPC Number: 10653160327899. c. Model Number: DT19810, UPC Number: 10653160285656. d. Model Number: CVI4915, UPC Number: 10653160355489. e. Model Number: IVS3770, UPC Number: 10653160328230. f. Model Number: DYNDV2407A, UPC Number: 019348981701. g. Model Number: MID0005, UPC Number: 10653160349181. h. Model Number: CVI4340, UPC Number: 10653160309475. i. Model Number: MIDST04011, UPC Number: 10653160350699. j. Model Number: MID0001, UPC Number: 10193489381627. k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334. l. Model Number: PICC0009A, UPC Number: 10193489760231. m. Model Number: DYNJ80152MB, UPC Number: 10889942733422. n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515. o. Model Number: DYNDC2120B, UPC Number: 10193489198270. p. Model Number: CVI3740A, UPC Number: 10653160324416. q. Model Number: IVS3990, UPC Number: 10653160345282. r. Model Number: CVI4450B, UPC Number: 10653160358428. s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436. t. Model Number: PICC0013, UPC Number: 10653160351818. u. Model Number: DT14560, UPC Number: 10653160236887. v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509. w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491. x. Model Number: DYNJ70152MB, UPC Number: 10889942722822. y. Model Number: BSIPIV1010, UPC Number: 10653160356523. z. Model Number: BSIPIV1004, UPC Number: 10193489198843. aa. Model Number: DYNJ68937A, UPC Number: 10193489111545. bb. Model Number: CVI3700, UPC Number: 10653160259763. cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391. dd. Model Number: IVS3350, UPC Number: 10653160313045. ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246. ff. Model Number: BSIPIV1006, UPC Number: 10653160356936. gg. Model Number: DYNDV2385, UPC Number: 10193489195217. hh. Model Number: IVS4075, UPC Number: 10653160350545. ii. Model Number: BSIPIV1011, UPC Number: 10653160353317. jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335. kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142. ll. Model Number: IVS3715, UPC Number: 10653160326298. mm. Model Number: IV8790, UPC Number: 019348936055. nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858. oo. Model Number: IVS3970, UPC Number: 10653160343431. pp. Model Number: CVI3910, UPC Number: 10653160272311. qq. Model Number: DT16125, UPC Number: 10653160254751. rr. Model Number: DYNDV2435, UPC Number: 019532704366. ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455. tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482. uu. Model Number: DYNDV2578, UPC Number: 10653160358374. vv. Model Number: IVS3910, UPC Number: 10653160338871. ww. Model Number: CVI3880, UPC Number: 10653160272755. xx. Model Number: STCVC2020A, UPC Number: 10653160350569. yy. Model Number: STCVC2015A, UPC Number: 10653160350552. zz. Model Number: DYNJ64871, UPC Number: 019348922536.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 35 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D; d. CENTRAL LINE TRAY, Model Number: DYNJ42902B; e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780; f. CLOSURE PACK, Model Number: DYNJ83054A; g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A; h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C; i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347; j. LINE KIT, Model Number: DYNJ47987A; k. PEDIATRIC CENTRAL LINE KIT, Model Number: DYNJ38885B; l. PK CUST CENTRAL LINE PACK, Model Number: DYNJ60586; m. TRAY LACERATION, Model Number: DYNDL1134A; n. TUNNEL LINE PACK, Model Number: DYNJ67990; o. ULTRASOUND GUIDED IV/MIDLINE K, Model Number: DYNDV2385;

Z-2324-2023
Recall number
Z-2324-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
19,907 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CVI3755, UPC Number: 019348981943. b. Model Number: DYNDC2582, UPC Number: 10889942670444; Model Number: DYNDC2582A, UPC Number: 10193489198164. c. Model Number: DYNJ47215D, UPC Number: 088827774302. d. Model Number: DYNJ42902B, UPC Number: 088827779800. e. Model Number: CVI3780, UPC Number: 019348943486. f. Model Number: DYNJ83054A, UPC Number: 019532731051. g. Model Number: DYNJ47717A, UPC Number: 019348945452. h. Model Number: P155508B, UPC Number: 019532709134; Model Number: P155508C, UPC Number: 019532709134. i. Model Number: DYNJ63347, UPC Number: 019348981031. j. Model Number: DYNJ47987A, UPC Number: 088994268310. k. Model Number: DYNJ38885B, UPC Number: 019348946233. l. Model Number: DYNJ60586, UPC Number: 019348952804. m. Model Number: DYNDL1134A, UPC Number: 008019699476. n. Model Number: DYNJ67990, UPC Number: 019348946253. o. Model Number: DYNDV2385, UPC Number: 019348947559.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 36 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464; d. MIDLINE INSERTION KIT, Model Number: DT20155; e. PICC LINE DRESSING TRAY, Model Number: DT22045; f. UNIVERSAL DRESSING PPE KIT, Model Number: DT22065; g. UNIVERSAL DRESSING & PPE KIT, Model Number: DT22065; h. VA MAINTENANCE PACK, Model Number: EBSI1382;

Z-2325-2023
Recall number
Z-2325-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
13,881 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CVI4770A, UPC Number: 10653160350828. b. Model Number: DT21275, UPC Number: 10653160318934. c. Model Number: EBSI1464, UPC Number: 10193489198959. d. Model Number: DT20155, UPC Number: 10653160290070. e. Model Number: DT22045, UPC Number: 10653160325659. f. Model Number: DT22065, UPC Number: 065316032660. g. Model Number: DT22065, UPC Number: 10653160326601. h. Model Number: EBSI1382, UPC Number: 10193489196269.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 37 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.

Z-2326-2023
Recall number
Z-2326-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
22 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ54326A, UPC Number: 019532732764.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 38 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C

Z-2327-2023
Recall number
Z-2327-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
144 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ58575C, UPC Number: 019532714414.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 39 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B

Z-2328-2023
Recall number
Z-2328-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
36 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ42065B, UPC Number: 088827789355.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 40 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219

Z-2329-2023
Recall number
Z-2329-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
154,900 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNDA1219, UPC Number: 10888277283879.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 41 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091

Z-2330-2023
Recall number
Z-2330-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
7,040 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYKA1456, UPC Number: 019532723188. b. Model Number: DYKL1844, UPC Number: 019532723181. c. Model Number: DYKM2091, UPC Number: 019348998356.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 42 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148; l. DBS PACK-LF, Model Number: DYNJ0878178I; m. GENERAL ANGIO PACK, Model Number: DYNJ57760A; n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C; o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N; p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A; q. MAIN BASIC NEURO, Model Number: DYNJ908260; r. NEURO ACCESSORY PACK, Model Number: DYNJ66790, DYNJ66790A, DYNJ66790B; s. NEURO CATH PACK, Model Number: DYNJ69129, DYNJ83090; t. NEURO IR PACK, Model Number: DYNJ35066I, DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C; u. NEURO PACK, Model Number: DYNJ43934A, DYNJ61798D, DYNJ66241, DYNJ66241A, DYNJ66241B, DYNJ66241C, DYNJ66241D, DYNJ68956A, DYNJ68956B; v. NEURO RADIOLOGY PACK, Model Number: DYNJ51107A, DYNJ59903A, DYNJ59903B; w. NEURO TRAY, Model Number: DYNJ67075, DYNJ67075A; x. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112A; y. PEDI ANGIO PACK-LF, Model Number: PHS41743B; z. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755C; aa. RADIOLOGY NEURO DRAPE PAC, Model Number: DYNJ61449; bb. RO-DIEP PACK, Model Number: DYNJ82393A;

Z-2331-2023
Recall number
Z-2331-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
15,945 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ905151A, UPC Number: 019348981341. b. Model Number: DYNJ58346A, UPC Number: 019348977463. c. Model Number: DYNJ57442C, UPC Number: 019348920853; Model Number: DYNJ64081A, UPC Number: 019348927374. d. Model Number: DYNJ65963, UPC Number: 019348930770. e. Model Number: DYNJ64655, UPC Number: 019348921040. f. Model Number: SPEC0232, UPC Number: 088827750741. g. Model Number: DYNJ62591A, UPC Number: 019348979331. h. Model Number: DYNJ39752A, UPC Number: 088438990723. i. Model Number: DYNJ53064B, UPC Number: 019348978916. j. Model Number: DYNJ64050, UPC Number: 019348978046. k. Model Number: DYKMBNDL148, UPC Number: 019348947839. l. Model Number: DYNJ0878178I, UPC Number: 019348956435. m. Model Number: DYNJ57760A, UPC Number: 019348922023. n. Model Number: DYNJ57032C, UPC Number: 019348945147. o. Model Number: DYNJ39198L, UPC Number: 019348956435 Model Number: DYNJ39198N, UPC Number: 019532710200. p. Model Number: DYNJ906086A, UPC Number: 019348920868. q. Model Number: DYNJ908260, UPC Number: 019532701744. r. Model Number: DYNJ66790, UPC Number: 019348938243; Model Number: DYNJ66790A, UPC Number: 019348992247; Model Number: DYNJ66790B, UPC Number: 019532709926. s. Model Number: DYNJ69129, UPC Number: 019348989241; Model Number: DYNJ83090, UPC Number: 019532723093. t. Model Number: DYNJ35066I, UPC Number: 019348956435; Model Number: DYNJ35066J, UPC Number: 019532709107; Model Number: DYNJ60701A, UPC Number: 019348969378; Model Number: DYNJ60701B, UPC Number: 019348987733; Model Number: DYNJ60701C, UPC Number: 019532703379. u. Model Number: DYNJ43934A, UPC Number: 019348973360; Model Number: DYNJ61798D, UPC Number: 019348999263; Model Number: DYNJ66241, UPC Number: 019348932296; Model Number: DYNJ66241A, UPC Number: 019348993803; Model Number: DYNJ66241B, UPC Number: 019532705348; Model Number: DYNJ66241C, UPC Number: 019532709685; Model Number: DYNJ66241D, UPC Number: 019532713837; Model Number: DYNJ68956A, UPC Number: 019348987629; Model Number: DYNJ68956B, UPC Number: 019532709434. v. Model Number: DYNJ51107A, UPC Number: 019348971558; Model Number: DYNJ59903A, UPC Number: 019532704286; Model Number: DYNJ59903B, UPC Number: 019532713120. w. Model Number: DYNJ67075, UPC Number: 019348938847; Model Number: DYNJ67075A, UPC Number: 019532705453. x. Model Number: DYNJ60112A, UPC Number: 019348924703. y. Model Number: PHS41743B, UPC Number: 019348978493. z. Model Number: DYNJ54755C, UPC Number: 019348977837. aa. Model Number: DYNJ61449, UPC Number: 019348956734. bb. Model Number: DYNJ82393A, UPC Number: 019532729232.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 43 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model Number: DYNDV2397; d. VAD ACCESS, Model Number: DYNJ24276C; e. VAGINAL DELIVERY TRAY, Model Number: DYNJ27275

Z-2332-2023
Recall number
Z-2332-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
9,319 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ66041A, UPC Number: 019348948028; Model Number: DYNJ66041B, UPC Number: 019532715107. b. Model Number: DYNJ62319A, UPC Number: 019348947486; Model Number: DYNJ62319B, UPC Number: 019348999548. c. Model Number: DYNDV2397, UPC Number: 019348938846. d. Model Number: DYNJ24276C, UPC Number: 088438943118. e. Model Number: DYNJ27275, UPC Number: 008019683311.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 44 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;

Z-2333-2023
Recall number
Z-2333-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
7,462 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ902540N, UPC Number: 019348991666. b. Model Number: DYNJ63257B, UPC Number: 019348942817. c. Model Number: DYNJ0771979C, UPC Number: 019348940069. d. Model Number: DYNJ906578F, UPC Number: 019532728963. e. Model Number: DYNJ906579F, UPC Number: 019532728964. f. Model Number: DYNJ906616G, UPC Number: 019532728947. g. Model Number: DYNJ905824I, UPC Number: 019532728972. h. Model Number: DYNJ906578D, UPC Number: 019532721712. i. Model Number: DYNJ906579A, UPC Number: 019348942214; Model Number: DYNJ906579B, UPC Number: 019348986153; Model Number: DYNJ906579D, UPC Number: 019532721713; Model Number: DYNJ906579F, UPC Number: 019532728964. j. Model Number: DYNJ906616A, UPC Number: 019348942213; Model Number: DYNJ906616B, UPC Number: 019348986167; Model Number: DYNJ906616C, UPC Number: 019532702358; Model Number: DYNJ906616D, UPC Number: 019532714503; Model Number: DYNJ906616F, UPC Number: 019532721728. k. Model Number: DYNJ0752001K, UPC Number: 019348978302. l. Model Number: DYNJ904343D, UPC Number: 019348991389; Model Number: DYNJ904343F, UPC Number: 019532714890. m. Model Number: DYNJ60009B, UPC Number: 019532705797; Model Number: DYNJ60009C, UPC Number: 019532720643. n. Model Number: DYNJ904250G, UPC Number: 019532717379. o. Model Number: DYNJ905826G, UPC Number: 019532728973. p. Model Number: DYNJ904254G, UPC Number: 019532700342; Model Number: DYNJ904254I, UPC Number: 019532704701. q. Model Number: DYNJ905824F, UPC Number: 019532702351; Model Number: DYNJ905824G, UPC Number: 019532721704; Model Number: DYNJ905824I, UPC Number: 019532728972. r. Model Number: DYNJ64027A, UPC Number: 019532705798; Model Number: DYNJ64027B, UPC Number: 019532720644.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 45 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;

Z-2334-2023
Recall number
Z-2334-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
371 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ64862A, UPC Number: 019348942033. b. Model Number: DYKL1816, UPC Number: 019532705432. c. Model Number: DYNJ908118A, UPC Number: 019532730349.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 46 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d. PERI NEURO BLOCK PACK-LF, Model Number: PHS762887001B; e. PICC TRAY, Model Number: DYNJ32988; f. SLING PACK-LF, Model Number: DYNJ55361, DYNJ55361A; g. TRANS VAGINAL TRAY (KW01JF), Model Number: OBQ056E; h. TVS4700 CUSTOM PACK, Model Number: TVS4700;

Z-2335-2023
Recall number
Z-2335-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
6,340 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ63257C, UPC Number: 019348993830. b. Model Number: DYNJ906578C, UPC Number: 019532702355. c. Model Number: DYNJ9048708I, UPC Number: 019532707273. d. Model Number: PHS762887001B, UPC Number: 088994284931. e. Model Number: DYNJ32988, UPC Number: 088438924278. f. Model Number: DYNJ55361, UPC Number: 088994254669; Model Number: DYNJ55361A, UPC Number: 019532717352. g. Model Number: OBQ056E, UPC Number: 088827758937. h. Model Number: TVS4700, UPC Number: 081698202339.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 47 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P; c. TVT PACK SMGH-LF, Model Number: DYNJ41913C;

Z-2336-2023
Recall number
Z-2336-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
211 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ66291B, UPC Number: 019532715117. b. Model Number: CDS840214P, UPC Number: 019348944319. c. Model Number: DYNJ41913C, UPC Number: 019348967757.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 48 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;

Z-2337-2023
Recall number
Z-2337-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
624 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ58351A, UPC Number: 088827773939. b. Model Number: DYNJ63341B, UPC Number: 019348995809.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 49 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A; e. CRANIOTOMY CDS, Model Number: CDS981753L; f. CRANIOTOMY CDS-1, Model Number: CDS982889I; g. CRANIOTOMY PACK, Model Number: DYNJ61749A; h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722; i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E; j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168; k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169; l. HYBRID PACK, Model Number: DYNJ56907D; m. IR ARM PACK, Model Number: DYNJ50712C; n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D; o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A; p. OASC IVF PACK, Model Number: DYNJ53035B; q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619; r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C; s. SCO ARTHROSCOPY, Model Number: DYNJ906551A; t. SHOULDER BLOCK KIT , Model Number: DYKS1241A; u. SHOULDER PACK-LF, Model Number: PHS41748D; v. TAA AAA, Model Number: DYNJ63339D; w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L; x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420; y. TUNNEL PACK, Model Number: DYNJ58127B; z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F; aa. US JOINT KIT, Model Number: DYNJRA1944; bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D, DYNJ63373F;

Z-2338-2023
Recall number
Z-2338-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
15,323 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ65963A, UPC Number: 019348999205. b. Model Number: PAIN1524B, UPC Number: 019348999446. c. Model Number: PAIN1524A, UPC Number: 019348932800. d. Model Number: DYNJ63149A, UPC Number: 019348978647. e. Model Number: CDS981753L, UPC Number: 019532723862. f. Model Number: CDS982889I, UPC Number: 088994220806. g. Model Number: DYNJ61749A, UPC Number: 019532706301. h. Model Number: DYNDH1722, UPC Number: 019532713216. i. Model Number: OST011E, UPC Number: 088827758932. j. Model Number: DYNJ909168, UPC Number: 019532728659. k. Model Number: DYNJ909169, UPC Number: 019532728660. l. Model Number: DYNJ56907D, UPC Number: 019348983156. m. Model Number: DYNJ50712C, UPC Number: 019348987016. n. Model Number: SPEC0204D, UPC Number: 019348930298. o. Model Number: DYNJ69312, UPC Number: 019348992946; Model Number: DYNJ69312A, UPC Number: 019532721677. p. Model Number: DYNJ53035B, UPC Number: 088827776381. q. Model Number: DYNJRA1619, UPC Number: 019348931184. r. Model Number: PHS392881009C, UPC Number: 019348922233. s. Model Number: DYNJ906551A, UPC Number: 019532712408. t. Model Number: DYKS1241A, UPC Number: 019348948809. u. Model Number: PHS41748D, UPC Number: 019348978479. v. Model Number: DYNJ63339D, UPC Number: 019532727360. w. Model Number: DYNJ51672J, UPC Number: 019348958962; Model Number: DYNJ51672K, UPC Number: 019532711224; Model Number: DYNJ51672L, UPC Number: 019532722130. x. Model Number: DYNJ908420, UPC Number: 019532707336. y. Model Number: DYNJ58127B, UPC Number: 019348948279. z. Model Number: SPEC0205F, UPC Number: 019348921288. aa. Model Number: DYNJRA1944, UPC Number: 019532713304. bb. Model Number: DYNJ63373B, UPC Number: 019348929206; Model Number: DYNJ63373C, UPC Number: 019348995812; Model Number: DYNJ63373D, UPC Number: 019532708615; Model Number: DYNJ63373F, UPC Number: 019532727078.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

device · product 50 of 50

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREAST BIOPSY KIT, Model Number: DYNDA1224A, DYNDA1224B; b. BREAST BIOPSY TRAY, Model Number: SPEC0130C; c. BREAST IMAGING TRAY, Model Number: MNS11895; d. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496; e. ULTRASOUND GUIDE BREAST BIOPSY, Model Number: DYNDH1319; f. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;

Z-2339-2023
Recall number
Z-2339-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
9,017 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Code information

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNDA1224A, UPC Number: 10888277985643; Model Number: DYNDA1224B, UPC Number: 10193489191448. b. Model Number: SPEC0130C, UPC Number: 10193489196641. c. Model Number: MNS11895, UPC Number: 10653160324645. d. Model Number: DYNDH1496, UPC Number: 10193489193947. e. Model Number: DYNDH1319, UPC Number: 10889942795475. f. Model Number: DYNDH1187A, UPC Number: 10889942702633.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.