Medical Device Recall: 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
Cardinal Health 200, LLC · November 8, 2024
Reason for Recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Product Description
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
States Affected
NATIONWIDE
Quantity Affected
512,786 total units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0914-2025
Status: ongoing
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