BEUDAMED
    FDA Enforcement Class II Ongoing

    GEM FLOW COUPLER Monitor, PN 5156-00000-011

    Recall: Z-2208-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2208-2023
    Event ID
    92525
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    June 19, 2023
    Classification Date
    July 20, 2023
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    GEM FLOW COUPLER Monitor, PN 5156-00000-011

    Reason

    An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

    Code Info

    GTIN 00844735006148, all serial numbers

    Distribution

    US

    Quantity

    122 units