FDA recall Z-0458-2022

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-11-22

Report date

2022-01-12

Termination date

2023-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2022