FDA-Device2025-01-22Class II
Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;
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 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2025Don't want to check this manually?
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