FDA Medical devices recall ·
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK recall
- Recall number
- Z-0910-2025
- Date
- (initiated November 8, 2024)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 512,786 total units
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cardinal 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
Why was it recalled?
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 ; C
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0910-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.