FDA recall Z-1133-2025

Cardinal Health 200, LLC · Class II · device

Product

Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC

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-1133-2025