Home / Recalls / Medical Devices
Uromedica Inc. recalls UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Recalled January 12, 2022 · FDA recall Z-0458-2022 · Uromedica
Hazard
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. · FDA Class II
Units
18 devices
Sold at
US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Description
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Product
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Manufacturer(s)
Uromedica Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →