Cardinal Health Laryngoscopy Presource Kits Recalled for Endotoxin Contamination
Cardinal Health is recalling 512,786 Laryngoscopy Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the United States, Canada, and Saudi Arabia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential serious hazard but no reported illnesses or injuries. Endotoxin contamination in surgical kits presents risk of harm, but the source explicitly describes this as potential contamination without reported adverse events, placing this at score 3 per the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling Laryngoscopy Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The affected kits include multiple catalog numbers (SEN11LGUH2, SEN11LGUH3, SEN11LGUH4, SEN11LGUH5, and SEN11LGUHB) with specific lot numbers identified by the manufacturer. A total of 512,786 units were distributed to the United States, Canada, and Saudi Arabia.
Endotoxin is a bacterial toxin that can trigger serious inflammatory responses in the body. In surgical settings, contact between endotoxin-contaminated items and sterile tissues can lead to complications.
The FDA classified this as a Class II recall. Healthcare facilities that received affected kits should identify and quarantine them immediately using the provided lot numbers.
Facilities should stop using the recalled kits and contact Cardinal Health for return or replacement instructions. Any adverse events or complications potentially related to these kits should be reported to the FDA through the MedWatch program.
The recalled product
- 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, Cata
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kit
- Hazard
- endotoxin-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog Number SEN11LGUH2
- UDI/DI 10195594093310 (EA)50195594093318 (CS)
- Lot Number J86T83
- Catalog Number SEN11LGUH3
- UDI/DI 10195594169626 (EA)50195594169624 (CS)
- Lot Number 5140349
- Catalog Number SEN11LGUH4
- UDI/DI 10195594230333 (EA)50195594230331 (CS)
- Lot Number 5405627
- Catalog Number SEN11LGUH5
- UDI/DI 10195594321871 (EA)50195594321879 (CS)
- Lot Number J6278U
- Catalog Number SEN11LGUHB
- UDI/DI 10887488360911 (EA)50887488360919 (CS)
- Lot Number J43U76
- Lot Number J5679F
- Lot Number J5679G
- Lot Number J74A30
- Lot Number J8064Z
- Lot Number J8123W
Distribution
Distributed nationwide across the United States.
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