BEUDAMED
    FDA Recall Terminated

    KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 Intended use: Imaging film

    Recall: Z-1314-2010 · Initiated March 12, 2010

    Recall

    Recall Number
    Z-1314-2010
    Event Number
    54981
    Firm
    Carestream Health, Inc.
    FEI Number
    1315356
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 12, 2010
    Posted
    April 8, 2010
    Terminated
    July 7, 2010
    Address
    150 Verona Street, Rochester, NY, 14608-1733

    Description

    KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 Intended use: Imaging film

    Reason

    Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.

    Action

    A "MEDICAL DEVICE RECALL (VOLUNTARY)" letters and Response Forms (dated 3/12/10) were sent to the customers on 3/12/10 via Certified Mail, Return Receipt Requested. The foreign sales offices are being notified via e-mail (started on 3/12/10) so that they in turn can notify the foreign consignees of the recall action and report back to Carestream Health. The letter describes the products, problem and action to be taken by the customers. The customers should identify and remove from inventory shelves any product that is listed in the recall, complete and return the attached Product Information Form whether they have affected product or not by fax to Carestream Health Customer Service 1-800-445-9967. Carestream Health will organize the return through designated carriers and will pay for transportation; and supply replacement stock in a timely manner. If you have any questions, concerns, or product technical questions, please call or fax Customer Service or Technical support at 1-800-328-2910.

    Distribution

    Worldwide distribution: USA and Puerto Rico, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand

    Quantity

    560 boxes