BEUDAMED
    FDA Recall Terminated

    Cold Therapy Blanket

    Recall: Z-0577-05 · Initiated November 22, 2004

    Recall

    Recall Number
    Z-0577-05
    Event Number
    30701
    Firm
    DeRoyal Technologies Inc
    FEI Number
    3003040625
    Product Code
    ILO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 22, 2004
    Posted
    March 9, 2005
    Terminated
    September 13, 2005
    Address
    1595 Highway 33 South, New Tazewell, TN, 37825-7105

    Description

    Cold Therapy Blanket

    Reason

    There is a possibility of water leaking from the welded seam of the blanket.

    Action

    Recall notification was sent out via UPS 2nd day air on 11/22/2004 requesting return of the product and a sub recall if the product was further distributed.

    Distribution

    Nationwide and Mexico VA Contrat FSS Contract #V797P-4352a (Sept 2002-2007) DoD Contract - DAPA Contract #SP0200-95H-5020 (continous)

    Quantity

    5084 units