Cardinal Health Presource Kits: 1) KIT recalled over sterility concerns
- Recall date
- November 8, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Cat…
- Recall number
- Z-1133-2025
- FDA classification
- Class II
- Brand / firm
- Cardinal Health 200, LLC
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Why it was recalled
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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