BEUDAMED
    FDA Enforcement Class I Ongoing

    Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

    Recall: Z-1141-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1141-2023
    Event ID
    91506
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2023
    Initiation Date
    January 25, 2023
    Classification Date
    February 24, 2023
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

    Reason

    There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

    Code Info

    a) REF BT200011, UDI 00887761978089, Serial Numbers: L190606-014, L191011-040, L200127-015, L200204-013; b) REF BT-20-0011, UDI 00887761978089, Serial Numbers: L200226-012, L200226-013, L200226-015

    Distribution

    Nationwide

    Quantity

    8 units