FDA recall Z-1137-2025

Cardinal Health 200, LLC · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2024-11-08
Report date
2025-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2025