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

Recall Z-1808-2020 — ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.

U.S. FDA — Device Enforcement · United States · 2019-04-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1808-2020
Date of alert
2019-04-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Uromedica Inc.
Product category
device
Product type
Devices
Reported risk: Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
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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