FDANovember 22, 2021device
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
uromedica
UPCs
00180668000106
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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