Cardinal Health Presource Kits: 1 ) KIT 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 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numbe…

Recall number

Z-0914-2025

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 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8 6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9 7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR