BEUDAMED
    FDA Recall Terminated

    Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.

    Recall: Z-2403-2010 · Initiated August 29, 2007

    Recall

    Recall Number
    Z-2403-2010
    Event Number
    56335
    Firm
    Invacare Corporation
    FEI Number
    1031452
    Product Code
    FMW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 29, 2007
    Posted
    September 12, 2010
    Terminated
    September 13, 2010
    Address
    2101 E. Lake Mary Blvd., Sanford, FL, 32773

    Description

    Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.

    Reason

    In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007 and July 12, 2007. These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric a

    Action

    Consignees of the product were notified by letter dated 09/05/2007. Consignees were instructed to destroy the affected mattresses and to return the completed confirmation of the destruction form to Invacare.

    Distribution

    Nationwide Distribution

    Quantity

    4896