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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health Presource Kits

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 Class 2 Device Recall Cardinal Health Presource Kitssee related information
Date Initiated by FirmNovember 08, 2024
Date PostedJanuary 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0910-2025
Recall Event ID 95722
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductCardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7
Code Information Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J5678Z ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J6049R ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J53W78 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J74A27 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J7412G ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J6050A ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8124C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8393C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J7905J ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J6367G ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J9602R ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J9602W ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number J6367C ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number 5136034 ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number J9850D ;
FEI Number 3001236905
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information ContactCardinal Health Quality Systems
800-292-9332
Manufacturer Reason
for Recall		Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT: PRODUCT RECALL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. REVIEW your inventory immediately stop using the affected product code and lots attached. 2. COMMUNICATE with all personnel who utilize the Presource Kits containing CODMAN Patties & Strips component produced by Integra LifeSciences. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product or to whom you plan to send the product about this medical device product correction and share a copy of this notice. 1. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMBFieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. For Presource kit credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits, please notify your customers of this recall. In the event you have experienced quality problems or adverse events related to the products listed above, please utilize the contacts above to report the event. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
Quantity in Commerce512,786 total units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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