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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Cardinal Health 200, LLC: Medical Kits and Trays Recalled Due to Faulty Syringes

Agency Publication Date: July 10, 2024
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Summary

Cardinal Health is recalling 170,209 Presource medical kits and trays because they contain syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. that may have been modified in design. These syringes, which are components within various angiography, cardiac catheterization, and neurological procedure packs, could significantly alter the safety and effectiveness of the entire kit. Consumers should be aware that using these affected kits could lead to patient harm from improper medication delivery or device failure.

Risk

The affected syringes may have design changes that cause them to leak or provide inaccurate dosing during medical procedures, potentially leading to serious patient injury or ineffective treatment.

What You Should Do

  1. Immediately identify if you have any affected Presource kits by checking the Catalog Number and Lot Number on the outer packaging. Affected catalog series include SAN13BS, SAN13CLET, SAN21AGE, SAN21NAJ, SAN22CVW, SAN37ASMO, SAN57PD, SAN5BCLS, SAN73CHS, SAN7AAPH, SAN7CAGGR, SANCGADA, SANDHCCC, SANOCCPJ, SANOCIRR, SBA73SPV, SCV56RH, SAN69CCK, SAN73CCV, SAN29ANCC, SAN33CDC, SANOCAEN, SAN73LHK, SAN29NI, SAN29NR, SANV1NI, SANV2INE, SNE29NR, SNECGME, SNECGNI, and SNEMHNT.
  2. Check specific lot numbers such as 358969, 683419, 866520, 887311, and the extensive list of other identifiers provided in the product records to confirm if your specific unit is part of the recall.
  3. Stop using and quarantine any affected kits or trays immediately to prevent them from being used in clinical settings.
  4. Contact your healthcare provider or Cardinal Health to discuss the disposition of these products and to arrange for replacements or further technical guidance.
  5. For detailed instructions or to report a problem, contact Cardinal Health directly or reach out to the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and disposition follow-up

How to: Contact your healthcare provider or the manufacturer for further instructions regarding the disposition of the affected Jiangsu Shenli syringes within the kits and potential refund.

Affected Products

Product: Presource Angiography Packs
Model / REF:
SAN13BS605
SAN13BS606
SAN13BS607
SAN13BS608
SAN13BS609
SAN13BS60K
SAN13BS60L
SAN13BS60M
SAN13BS60N
SAN13BS60O
UPC Codes:
50888439661574
10888439661576
50195594317339
10195594317331
50195594746986
10195594746988
50195594778772
10195594778774
50197106253227
10197106253229
50887488801436
10887488801438
50888439596357
10888439596359
50195594473073
10195594473075
50195594635730
10195594635732
50195594796813
10195594796815
Lot Numbers:
358969
683419
866520
887311
39241
229810
262632
276480
297564
317663
375743
413389
430039
456790
480663
505742
530846
555938
578665
608032
616691
636514
660643
689306
750483
766968
785075
814888
832379
893931
14519
55994
72799
82775
89384
111731
114055
131433
156021
177997
213162
264000
911967
930128
950922
971740
991212
Product: Presource Cath Lab Packs
Model / REF:
SAN13CLET2
SAN13CLETC
SAN13CLETD
UPC Codes:
50197106250646
10197106250648
50888439268834
10888439268836
50195594942180
10195594942182
Lot Numbers:
36883
230539
246895
287853
327203
347971
369115
410044
436785
465770
485295
497198
509738
546865
568745
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
Product: Presource Cardiac Catheterization Kits
Model / REF:
SAN69CCKRB
SAN73CCV10
SAN73CCV11
SAN73CCV12
SAN73CCV13
SAN73CCV14
SAN73CCVD8
SAN73CCVD9
SAN73CCVDG
SAN73CCVDH
SAN73CCVDI
UPC Codes:
50195594062079
10195594062071
50195594753557
10195594753559
50195594870773
10195594870775
50197106021987
10197106021989
50197106371433
10197106371435
50197106559763
10197106559765
50195594589613
10195594589615
50195594615961
10195594615963
50195594546531
10195594546533
50197106375516
10197106375518
50197106642007
10197106642009
Lot Numbers:
205373
870093
915202
934300
86630
209283
791638
803098
29048
52931
69859
821471
843529
890800
951235
980133
998592
106841
149021
227027
258282
265079

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94763
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Cardinal Health; Presource
Manufactured In: United States, China
Units Affected: 4 products (136753 units; 2524 units; 17445 units; 13487 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.