BEUDAMED
    FDA Enforcement Class II Terminated

    Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

    Recall: Z-0943-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0943-2022
    Event ID
    89776
    Classification
    Class II
    Status
    Terminated
    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
    April 20, 2022
    Initiation Date
    March 21, 2022
    Classification Date
    April 14, 2022
    Termination Date
    December 13, 2024
    Address
    16 Esquire Rd, N/A, North Billerica, MA, 01862-2527, United States

    Description

    Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

    Reason

    Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

    Code Info

    Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849

    Distribution

    US Nationwide

    Quantity

    707 units