BEUDAMED
    FDA Enforcement Class I Ongoing

    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)

    Recall: Z-2690-2024 · Reported September 11, 2024

    Enforcement

    Recall Number
    Z-2690-2024
    Event ID
    95042
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Breas Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2024
    Initiation Date
    July 25, 2024
    Classification Date
    September 3, 2024
    Address
    16 Esquire Rd, North Billerica, MA, 01862-2527, United States

    Description

    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)

    Reason

    There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.

    Code Info

    Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.

    Distribution

    US Nationwide.

    Quantity

    8298