BEUDAMED
    FDA Recall Terminated

    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

    Recall: Z-2142-2014 · Initiated July 2, 2014

    Recall

    Recall Number
    Z-2142-2014
    Event Number
    68647
    Firm
    Carestream Health Inc.
    FEI Number
    1315356
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 2, 2014
    Posted
    August 1, 2014
    Terminated
    May 25, 2016
    Address
    150 Verona St, Rochester, NY, 14608-1733

    Description

    INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

    Reason

    The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.

    Action

    Recall notices were mailed to US Customers via overnight carrier on 07/02/2014. Customers are asked to complete an inventory of goods to be returned which will be ultimately destroyed by recalling company. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.

    Distribution

    Worldwide Distribution.

    Quantity

    1633 boxes