BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1808-2020 · Initiated April 10, 2019

    Recall

    Recall Number
    Z-1808-2020
    Event Number
    85486
    Firm
    Uromedica Inc.
    FEI Number
    3003477176
    Product Code
    KOA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 10, 2019
    Terminated
    May 18, 2020
    Address
    1840 Berkshire Ln N, Plymouth, MN, 55441-3723

    Description

    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.

    Reason

    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.

    Action

    Uromedica sent a notification to the customers via email and letter instructing them to identify the affected sets and returned them to Uromedica within 10 business days. Uromedica will provide for the return shipping of the affected tool set and replace if free of charge.

    Distribution

    Nationwide distribution to the following states: CA, GA, FL, MI, and VA.

    Quantity

    11 tool sets