UROMEDICA Implantation Instrument Set recalled over sterility concerns

Recall date

November 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-0458-2022

FDA classification

Class II

Brand / firm

Uromedica Inc.

Sold / distributed

US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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