BEUDAMED
    FDA Enforcement Class II Terminated

    Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.

    Recall: Z-0728-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0728-2017
    Event ID
    74488
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ErgoSafe Products, LLC (DBA) Prism Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    August 30, 2016
    Classification Date
    December 9, 2016
    Termination Date
    July 18, 2018
    Address
    10888 Metro Ct, Maryland Heights, MO, 63043-2413, United States

    Description

    Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.

    Reason

    The black plastic puck on the carry bar is breaking resulting in potential for patient harm.

    Code Info

    There are no lot numbers, serial numbers, or UPC codes, only the model numbers. Model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.

    Distribution

    Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea

    Quantity

    not greater than 17,964 units