FDA-Device2025-01-22Class II
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
Cardinal Health 200, LLC
Hazard
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Affected count
512,786 total units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0914-2025Don't want to check this manually?
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