Recall Z-0912-2025— 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 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ; 5 ) STERILE LARYNGOSCOPY PACK, Catalog Number: SEN11LGUHB. 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 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ; 5 ) STERILE LARYNGOSCOPY PACK, Catalog Number: SEN11LGUHB
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.