BEUDAMED
    FDA Recall Terminated

    Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator

    Recall: Z-1674-2009 · Initiated May 8, 2009

    Recall

    Recall Number
    Z-1674-2009
    Event Number
    52129
    Firm
    Essential Medical Supply, Inc.
    FEI Number
    1000132434
    Product Code
    ITJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 8, 2009
    Posted
    July 20, 2009
    Terminated
    September 15, 2010
    Address
    6420 Hazeltine National Dr, Orlando, FL, 32822-5121

    Description

    Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator

    Reason

    The caster may separate from the frame completely causing injury to the user.

    Action

    Essential Medical Supply Inc issued a Notice of Quarantine Letter to all customers on 04/30/09, identifying affected products as W1700B & W1700R Essential Rollators, Serial #'s KLD-E07090001 through KLD-E08020570, received after 11/05/2007. Firm issued a Device Recall Letter to all direct customers on 05/08/09 instructing them to do the following: (1) segregate and quarantine any affected product; (2) identify and notify any customers that may received the affected products, instructing them to return the product to their dealer; and (3) either return the affected products to Essential Medical Supply or destroy the products and send proof of destruction.

    Distribution

    Nationwide distribution.

    Quantity

    2265