BEUDAMED
    FDA Enforcement Class II Ongoing

    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

    Recall: Z-0405-2024 · Reported December 6, 2023

    Enforcement

    Recall Number
    Z-0405-2024
    Event ID
    93331
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Breas Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 6, 2023
    Initiation Date
    October 13, 2023
    Classification Date
    November 27, 2023
    Address
    16 Esquire Rd, North Billerica, MA, 01862-2527, United States

    Description

    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

    Reason

    Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation

    Code Info

    UDI-DI: 05030267120505 NIV Angled Mouthpiece with Notch 22M/15F; 07321820060931 MPV Kit 006093; 07321820066537 MPV Kit 006653 MPV mouthpiece Lot Numbers: 32304444, 32305269 and 32306017

    Distribution

    Nationwide Foreign: Canada

    Quantity

    215 units