BEUDAMED
    FDA Enforcement Class II 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 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0370-2014
    Event ID
    66056
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ergosafe Products LLC DBA Prism Medical Services USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 27, 2013
    Initiation Date
    October 30, 2013
    Classification Date
    November 20, 2013
    Termination Date
    May 17, 2017
    Address
    45 Progress Pkwy, Maryland Heights, MO, 63043-3701, United States

    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.

    Code Info

    Serial numbers 0109STH0042, 0112STH0085, 0112STH0086, 0112STH0087, 0112STH0089, 0112STH0090, 0112STH0091, 0112STH0092, 1211STH0071, 0207STH0003, 0207STH0004, 0209STH0043, 0211STH0072, 0212STH0093, 0212STH0094, 0212STH0095, 0212STH0096, 0212STH0097, 0212STH0098, 0212STH0099, 0212STH0100, 0308STH0027, 0308STH0028, 0308STH0029, 0308STH0030, 0309STH0044, 0309STH0045, 0309STH0046, 0407STH0005, 0409STH0047, 0507STH0006, 0508STH0031, 0508STH0032, 0510STH0058, 0510STH0059, 0510STH0060, 0511STH0073, 0511STH0074, 0607STH0007, 0608STH0033, 0608STH0034, 0609STH0049, 0610STH0061, 0610STH0062, 0610STH0063, 0610STH0064, 0611STH0075, 0611STH0076, 0611STH0077, 0613STH0113, 0613STH0114, 0613STH0115, 0613STH0116, 0613STH0117, 0613STH0118, 0707STH0008, 0708STH0035, 0708STH0036, 0709STH0050, 0709STH0051, 0710STH0065, 0711STH0078, 0711STH0079, 0711STH0080, 0712STH0101, 0712STH0102, 0712STH0103, 0712STH0104, 0809STH0052, 0809STH0053, 0810STH0066, 0810STH0067, 0810STH0068, 0905STH0001, 0907STH0009, 0908STH0037, 0908STH0038, 0909STH0054, 0909STH0055, 0911STH0081, 0911STH0082, 1006STH0002, 1008STH0039, 1008STH0040, 1008STH0041, 1009STH0056, 1009STH0057, 1012STH0105, 1012STH0106, 1012STH0107, 1012STH0108, 1110STH0069, 1112STH0109, 1112STH0110, 1210STH0070, 1211STH0083, and 1211STH0084.

    Distribution

    Nationwide distribution.

    Quantity

    97 units