FDA-Device2025-01-22Class II
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
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, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0911-2025Don't want to check this manually?
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