medical Class II Updated 2022-01-12

Uromedica Inc. recalls UROMEDICA Implantation Instrument Set (Sheath and Sharp Troc

Recalled Product

UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.


Hazard / Issue

The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot numbers UM00794 and UM00817, UDI 00180668000106
View official government recall

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