Device product

Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

Z-1137-2025

November 08, 2024

Class II

Product summary

Firm: Cardinal Health 200, LLC
Event: Event 95947
Status: Ongoing
Classification: Class II
Quantity: 973,785 total units
Official record key: device-enforcement:Z-1137-2025

Official wording

Reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

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;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.