BEUDAMED
    FDA Recall 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 · Initiated August 30, 2016

    Recall

    Recall Number
    Z-0728-2017
    Event Number
    74488
    Firm
    ErgoSafe Products, LLC (DBA) Prism Medical
    FEI Number
    3007802293
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 30, 2016
    Terminated
    July 18, 2018
    Address
    10888 Metro Ct, Maryland Heights, MO, 63043-2413

    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.

    Action

    The recalling firm sent field safety notices to their customers by mail on August 30, 2016. The notice instructed customers to inspect their carry bar to see if it used a black plastic puck. If it did, they were instructed to contact the recalling firm to receive a metal insert to install. If the puck is cracked or damaged, they can request a new, replacement carry bar at a discounted price. For further questions, please call (866) 891-6502.

    Distribution

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

    Quantity

    not greater than 17,964 units