Reported Jul 17, 2024 · Ongoing
Presource kits and trays, labeled as
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
Presource kits and trays, labeled as
80 of 80 products
| Model / number | Product as published |
|---|---|
SAN13BS605 | ANGIOGRAPHY PACK |
SAN13BS606 | ANGIOGRAPHY PACK |
SAN13BS607 | ANGIOGRAPHY PACK |
SAN13BS608 | ANGIOGRAPHY PACK |
SAN13BS609 | ANGIOGRAPHY PACK |
SAN13BS60K | STERILE ANGIOGRAPHY PACK |
SAN13BS60L | ANGIOGRAPHY PACK |
SAN13BS60M | ANGIOGRAPHY PACK |
SAN13BS60N | ANGIOGRAPHY PACK |
SAN13BS60O | ANGIOGRAPHY PACK |
SAN13CLET2 | CATH LAB PACK |
SAN13CLETC | CATH LAB PACK |
SAN13CLETD | CATH LAB PACK |
SAN21AGE10 | ARTERIOGRAM PACK |
SAN21AGEG6 | ARTERIOGRAM PACK |
SAN21AGEG7 | ARTERIOGRAM PACK |
SAN21AGEG8 | ARTERIOGRAM PACK |
SAN21AGEG9 | ARTERIOGRAM PACK |
SAN21AGEGJ | ARTERIOGRAM PACK |
SAN21AGEGK | ARTERIOGRAM PACK |
- Lot codes and dates
110 of 110 products
Products covered by this recall # Barcodes Product as published 1 5088843966157410888439661576SAN13BS605, UDI/DI (CS/EA) 50888439661574/10888439661576, Lot Numbers: 358969 2 5019559431733910195594317331SAN13BS606, UDI/DI (CS/EA) 50195594317339/10195594317331, Lot Numbers: 683419 3 5019559474698610195594746988SAN13BS607, UDI/DI (CS/EA) 50195594746986/10195594746988, Lot Numbers: 866520 4 5019559477877210195594778774SAN13BS608, UDI/DI (CS/EA) 50195594778772/10195594778774, Lot Numbers: 887311 5 5019710625322710197106253229SAN13BS609, UDI/DI (CS/EA) 50197106253227/10197106253229, Lot Numbers: 39241 6 5088748880143610887488801438SAN13BS60K, UDI/DI (CS/EA) 50887488801436/10887488801438, Lot Numbers: 229810, 262632, 276480, 297564 7 5088843959635710888439596359SAN13BS60L, UDI/DI (CS/EA) 50888439596357/10888439596359, Lot Numbers: 317663, 375743, 413389, 430039, 456790, 480663, 505742, 530846, 555938, 578665, 608032, 616691, 636514, 660643, 689306 8 5019559447307310195594473075SAN13BS60M, UDI/DI (CS/EA) 50195594473073/10195594473075, Lot Numbers: 750483, 766968, 785075 9 5019559463573010195594635732SAN13BS60N, UDI/DI (CS/EA) 50195594635730/10195594635732, Lot Numbers: 814888, 832379, 893931 10 5019559479681310195594796815SAN13BS60O, UDI/DI (CS/EA) 50195594796813/10195594796815, Lot Numbers: 14519, 55994, 72799, 82775, 89384, 111731, 114055, 131433, 156021, 177997, 213162, 264000, 911967, 930128, 950922, 971740, 991212 11 5019710625064610197106250648SAN13CLET2, UDI/DI (CS/EA) 50197106250646/10197106250648, Lot Numbers: 36883 12 5088843926883410888439268836SAN13CLETC, UDI/DI (CS/EA) 50888439268834/10888439268836, Lot Numbers: 230539, 246895, 287853, 327203, 347971, 369115, 410044, 436785, 465770, 485295, 497198, 509738, 546865, 568745 13 5019559494218010195594942182SAN13CLETD, UDI/DI (CS/EA) 50195594942180/10195594942182, Lot Numbers: 10433, 41607, 68974, 111579, 111828, 120719, 132413, 140179, 187403, 195808, 247166, 267724, 280164, 606687, 636751, 664029, 688523, 714600, 735582, 770617, 803844, 827746, 845899, 861463, 890708, 894367, 906005, 923315, 944987, 952212, 989195 14 5019710625890110197106258903SAN21AGE10, UDI/DI (CS/EA) 50197106258901/10197106258903, Lot Numbers: 40930 15 5019559409266310195594092665SAN21AGEG6, UDI/DI (CS/EA) 50195594092663/10195594092665, Lot Numbers: 619968 16 5019559448978410195594489786SAN21AGEG7, UDI/DI (CS/EA) 50195594489784/10195594489786, Lot Numbers: 743830 17 5019559452436210195594524364SAN21AGEG8, UDI/DI (CS/EA) 50195594524362/10195594524364, Lot Numbers: 760050 18 5019710606876010197106068762SAN21AGEG9, UDI/DI (CS/EA) 50197106068760/10197106068762, Lot Numbers: 958044 19 5019559400409310195594004095SAN21AGEGJ, UDI/DI (CS/EA) 50195594004093/10195594004095, Lot Numbers: 653986, 666654, 702552, 767979, 806380, 817797, 831491, 848171, 870905, 888329, 908189, 925092 20 5019710607494510197106074947SAN21AGEGK, UDI/DI (CS/EA) 50197106074945/10197106074947, Lot Numbers: 16107, 62787, 95786, 123784, 123815, 143550, 170317, 969373, 982319, 998196 - Amount recalled
- 136753 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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