BEUDAMED
    FDA Enforcement Class II Terminated

    Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.

    Recall: Z-1578-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1578-2013
    Event ID
    65193
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Prism Medical Services USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    January 27, 2013
    Classification Date
    June 21, 2013
    Termination Date
    July 18, 2018
    Address
    45 Progress Pkwy, Maryland Heights, MO, 63043-3701, United States

    Description

    Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.

    Reason

    The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.

    Code Info

    model number 360755

    Distribution

    Worldwide distribution: US (nationwide) and country of: Canada.

    Quantity

    1131 carry bars/New England