medical Class II Updated 2020-05-06

Uromedica Inc. recalls ProACT Implantation Instrument Set, is a reusable, steam ste

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model 750041, Lot # UM00650
View official government recall

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