PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 22, 2025 Initiated: November 8, 2024 #Z-0910-2025

Product Description

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

Reason for Recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
512,786 total units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Cardinal Health 200, LLC. Units affected: 512,786 total units.
Why was this product recalled?
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0910-2025.