BEUDAMED
    FDA Enforcement Class II Terminated

    MediChoice Dual-Release Folding Walker with 5" wheel

    Recall: Z-0416-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0416-2015
    Event ID
    68780
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Owens & Minor Distribution, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2014
    Initiation Date
    June 25, 2014
    Classification Date
    November 20, 2014
    Termination Date
    January 6, 2017
    Address
    9120 Lockwood Blvd, N/A, Mechanicsville, VA, 23116-2015, United States

    Description

    MediChoice Dual-Release Folding Walker with 5" wheel

    Reason

    Product wheels may be too loose, too tight, or fall off.

    Code Info

    Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520; 1306CA07A 1307001521-1307002184; 1307CA07A 1307002185-1307002888; 1309CA07A 1307002889-1307003292; 1310CA07A 1307003293-1307004044; 1311CA07A 1307004045-1307004752; 1312CA07A 1307004753-1307005236;

    Distribution

    US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY.

    Quantity

    1214 cases; 4 units/case