BEUDAMED
    FDA Enforcement Class I Ongoing

    Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

    Recall: Z-0046-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0046-2025
    Event ID
    95398
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    September 12, 2024
    Classification Date
    October 22, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

    Reason

    The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.

    Code Info

    UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

    Distribution

    US nationwide distribution.

    Quantity

    10,957 units