Recall Z-0909-2025— Cardinal Health 200, LLC
Class II · Ongoing
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2024-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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:;. Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-08
- Firm location
- Waukegan, IL, United States
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:;
Reason for recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.