BEUDAMED
    FDA Enforcement Class II Terminated

    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.

    Recall: Z-0142-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0142-2015
    Event ID
    64774
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Briggs Medical Service Company d.b.a. Mabis
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    June 5, 2014
    Classification Date
    October 28, 2014
    Termination Date
    November 29, 2017
    Address
    1931 Norman Dr N, N/A, Waukegan, IL, 60085-6715, United States

    Description

    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.

    Reason

    There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.

    Code Info

    A) Model Number: 501-1018-0700; UPC Code: 0-41298-10187-1; Lot Numbers: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211; B) Model Number: 501-1018-2100; UPC Code: 0-41298-10182-6; Lots: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211

    Distribution

    Worldwide Distribution: US (nationwide) including states of:US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; and country of : Canada. ); FOREIGN: Canada

    Quantity

    1,869 units