Medical Device Recall: 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:;
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 ) 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:;
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-0909-2025
Status: ongoing
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