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    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.

    FDA Recall
    Terminated ·Uromedica Inc.·Product code KOA·April 10, 2019

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

    FDA Recall
    Terminated ·Uromedica Inc.·Product code EZY·November 22, 2021

    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.

    FDA Enforcement
    Class II ·Terminated·Uromedica Inc.·May 6, 2020

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

    FDA Enforcement
    Class II ·Terminated·Uromedica Inc.·January 12, 2022