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
    • PB4FRHWFA
    • 2) KIT
    • ROBOTIC HYSTERECTOMY
  • Catalog NumberPB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY
  • Catalog NumberPB4FRHWFC
Lot codes and dates

9 of 9 products

Products covered by this recall
#BarcodesProduct as published
11019710652700950197106527007PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 6701856
21019710652700950197106527007PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 7331357
31019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7266123
41019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7331357
51019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452
61019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333453
71019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7160530
81019710662809650197106628094PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452
91019710673231150197106732319PB4FRHWFC, 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.

Free recall alerts

Get alerted about new Cardinal Health 200, LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.