Z-1137-2025 Class II Ongoing
FDA device recall Z-1137-2025 was initiated by Cardinal Health 200, LLC on November 8, 2024 and is designated Class II. Reason for recall: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. The recall status is ongoing. Affected quantity: 973,785 total units.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- November 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 973,785 total units
Product Description
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Reason for Recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Code Information
1) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439880 (each) 50195594439888 (case), Lot Number: J65K18;