Medical device recalls Moderate risk

Cardinal Health Presource Kits: 1) ACDF 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) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Recall number
Z-1137-2025
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 for 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) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

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