Reported May 6, 2020 · Terminated
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel…
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?
- ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
- Lot codes and dates
Model 750041Lot # UM00650
- Amount recalled
- 11 tool sets
Where it was sold
Why it was recalled
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
This product could cause temporary or reversible health problems — stop using it.
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