Reported Oct 14, 2015 · Terminated
regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing cover light handle soft, RX. The…
Resource Optimization & Innovation 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: Resource Optimization & Innovation Llc · 2909 N Neergard Ave · Springfield, MO · 65803
Is this the product you have?
- regard Item Number800560001, Sterile, GS0649A - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
- Lot codes and dates
- Lot number 24255.
- Amount recalled
- 88 kits
This recall covers 77 products
The agency filed one notice per product. You are reading one of them; the other 76 are below.
64 more are in the archive.
Where it was sold
Why it was recalled
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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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