Reported Feb 19, 2025 · Ongoing
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY,…
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
- Cardinal Health Presource Kits1) KIT,ROBOTIC HYSTERECTOMY
- Catalog Number
PB4FRHWFA2) KITROBOTIC HYSTERECTOMY
- Catalog NumberPB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY
- Catalog NumberPB4FRHWFC
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 1019710652700950197106527007PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 6701856 2 1019710652700950197106527007PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 7331357 3 1019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7266123 4 1019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7331357 5 1019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 6 1019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333453 7 1019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7160530 8 1019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 9 1019710673231150197106732319PB4FRHWFC, UDI-DI:10197106732311 (each) 50197106732319 (case), Lot Number: 7350003 - Amount recalled
- 973,785 total units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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