BEUDAMED
    FDA Recall Terminated

    Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.

    Recall: Z-0370-2014 · Initiated October 30, 2013

    Recall

    Recall Number
    Z-0370-2014
    Event Number
    66056
    Firm
    Ergosafe Products LLC DBA Prism Medical Services USA
    FEI Number
    3007802293
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 30, 2013
    Posted
    November 20, 2013
    Terminated
    May 17, 2017
    Address
    45 Progress Pkwy, Maryland Heights, MO, 63043-3701

    Description

    Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.

    Reason

    The lift might fail with the labeled 500-lb. load rating.

    Action

    The firm, Medcare Products, sent an "URGENT FIELD CORRECTIVE ACTIONS" letter dated October 21, 2013 via certified mail on October 30, 2013 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to peel off the boom stickers and serial number label and replace with the new ones supplied; review the revised Manual and dispose of the original; and complete the action report form once the products have been relabeled. Please refer to your Operations Manual or visit our website at www.medcarelifts.com to view the manual online. If we can answer any questions that you may have regarding the testing standards or the relabeling of the products, please do not hesitate to contact us at 1-800-695-4479.

    Distribution

    Nationwide distribution.

    Quantity

    97 units