Cardinal Health Presource Kits: 1 ) ANEURYSM PACK recalled over sterility concerns

Recall date

November 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCV…

Recall number

Z-0910-2025

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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