BEUDAMED
    FDA Recall Terminated

    Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

    Recall: Z-2656-2014 · Initiated July 21, 2014

    Recall

    Recall Number
    Z-2656-2014
    Event Number
    69057
    Firm
    GF Health Products, Inc./d.b.a.Basic American Metal Products
    FEI Number
    2183191
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 21, 2014
    Posted
    September 16, 2014
    Terminated
    August 11, 2015
    Address
    336 Trowbridge Dr, Fond Du Lac, WI, 54937-9103

    Description

    Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

    Reason

    The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended.

    Action

    Consignees were sent a Basic American Medical Products "Product Field Correction Notice" dated July 21, 2014. The letter provided the background information on the recall and the " Required Action" to be taken which includes the replacement of the head deck. Consignees need to contact 1-888-974-4347 to scheduled the replacement order. The replaced head decks should be disposed and disposal documented on the enclosed Letter of Disposal Agreement. The completed letter needs to be returned to Basic American Medical Products. For additional questions they can contact the Field Correction Coordinator at 1-888-974-4347 or electronically: [email protected].

    Distribution

    Worldwide Distribution: USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA,MI, MN, MS, MO,MT, NE, NH, NJ, NM, NY,M NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, LT, VA, WA, WV, and WI and PUERTO RICO and the country of CANADA.

    Quantity

    1941