FDA Medical devices recall ·
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK recall
- Recall number
- Z-0912-2025
- Date
- (initiated November 8, 2024)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 512,786 total units
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J5679F ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J5679F ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J5679G ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J74A30 ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8064Z ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8123W ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8393U ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8692W ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8671P ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J86T83 ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number 566
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0912-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.