Class II

Medical Device Recall: 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 · November 8, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

973,785 total units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1133-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Cardinal Health 200, LLC Medical Device Recall: 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 | SafeCheck