BEUDAMED
    FDA Enforcement Class I Terminated

    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

    Recall: Z-0021-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0021-2020
    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 Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

    Reason

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

    Code Info

    UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)

    Distribution

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

    Quantity

    12000