BEUDAMED
    FDA Recall Terminated

    LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.

    Recall: Z-1536-2012 · Initiated April 17, 2012

    Recall

    Recall Number
    Z-1536-2012
    Event Number
    61527
    Firm
    GF Health Products, Inc./d.b.a.Basic American Metal Products
    FEI Number
    2183191
    Product Code
    LLI
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    April 17, 2012
    Posted
    May 11, 2012
    Terminated
    July 15, 2013
    Address
    336 Trowbridge Dr, Fond Du Lac, WI, 54937-9103

    Description

    LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.

    Reason

    GF Health Products, Inc., is conducting a recall on the Lumex Patriot Full Electric Homecare "Bed Ends" manufactured 3/27/09, 5/9/09, 5/30/09 and 6/20/09. The supplier deviated from the print specifications of a machined pin to a sheared pin. This deviation has the potential to provide room for the pin to move during use. If failure were to occur, the bed could descend rapidly causing non-typic

    Action

    GF Health Products, Inc. sent an "URGENT CORRECTION AND REMOVAL" letter dated April 17, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately cease use of the affected product, secure the product, and to prevent the product from further distribution to customers and end users. Contact the firm at 1-800-556-6508 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WI and the countries of EL SALVADOR, CHILE, GUATEMALA, TRINIDAD, TOBAGO, and BAHAMAS.

    Quantity

    3095 pairs of bed ends