Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0458-2022 — UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.

U.S. FDA — Device Enforcement · United States · 2021-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0458-2022
Date of alert
2021-11-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Uromedica Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00180668000106
Reported risk: The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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