BEUDAMED
    FDA Enforcement Class I Terminated

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

    Recall: Z-0022-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0022-2020
    Event ID
    83318
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Galemed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    May 30, 2019
    Classification Date
    December 20, 2019
    Termination Date
    May 20, 2024
    Address
    87 Wu-Jia, Li-Gong 2nd Road, I-Lan, N/A, Taiwan

    Description

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

    Reason

    Reports of pressure relief manifold venting gas below the standard pressure.

    Code Info

    UDI: 04710810100802 Lot: 180806, 180910, 181029, 181105, 181204, 190225, 190327

    Distribution

    US distribution to distributors in the states of: NC and NV.

    Quantity

    14964