FDA-Device2025-02-19Class II
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
Cardinal Health 200, LLC
Hazard
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Affected count
973,785 total units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief