FDA Enforcement
Class II
Ongoing
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Recall: Z-1137-2025
·
Reported February 19, 2025
Enforcement
- Recall Number
- Z-1137-2025
- Event ID
- 95947
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 19, 2025
- Initiation Date
- November 8, 2024
- Classification Date
- February 10, 2025
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States
Description
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Reason
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Code Info
1) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439880 (each) 50195594439888 (case), Lot Number: J65K18;
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Quantity
973,785 total units