BEUDAMED
    FDA Enforcement Class I Ongoing

    Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

    Recall: Z-0887-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0887-2025
    Event ID
    95842
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 20, 2024
    Classification Date
    January 16, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

    Reason

    There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

    Code Info

    UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081

    Distribution

    US, Nationwide Distribution

    Quantity

    1 unit