FDA-Device2025-02-19Class II
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Cardinal Health 200, LLC
Hazard
Potential for 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
973,785 total units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2025Don't want to check this manually?
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