BEUDAMED
    FDA Recall Terminated

    DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608. General purpose radiography.

    Recall: Z-0746-2012 · Initiated December 20, 2011

    Recall

    Recall Number
    Z-0746-2012
    Event Number
    60736
    Firm
    Carestream Health, Inc.
    FEI Number
    1315356
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 20, 2011
    Posted
    January 13, 2012
    Terminated
    May 17, 2016
    Address
    150 Verona Street, Rochester, NY, 14608-1733

    Description

    DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608. General purpose radiography.

    Reason

    Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density.

    Action

    Carestream Health Inc. sent an "URGENT PRODUCT REMOVAL" letter dated December 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to identify, segregate, and return any affected product to the firm. A Product Information Form was attached to the letter for customers to complete and return via fax to 541-831-7101. Contact Technical Support at 1-800-328-2910 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of Alabama, Florida, Georgia, and Tennessee and the country of Australia.

    Quantity

    24 cartridges