Cardinal Health 200, LLC: Device Recall
Recall #Z-1127-2025 · 11/08/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1127-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Cardinal Health 200, LLC
- Status
- Ongoing
- Date Initiated
- 11/08/2024
- Location
- Waukegan, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 973,785 total units
Reason for Recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Product Description
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Other Recalls by Cardinal Health 200, LLC
- Class II: Risk 12/26/2025
- Class II: Risk 11/12/2025
- Class II: Risk 09/18/2025
- Class II: Risk 09/18/2025
- Class II: Risk 09/18/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.