Reported Jan 12, 2022 · Terminated
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Uromedica Inc.
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: Uromedica Inc. · 1840 Berkshire Ln N · Plymouth, MN · 55441-3723
Is this the product you have?
- UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
- Lot codes and dates
Lot numbers UM00794 and UM00817UDI 00180668000106
- Amount recalled
- 18 devices
Where it was sold
Why it was recalled
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
This product could cause temporary or reversible health problems — stop using it.
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