BEUDAMED
    FDA Recall Terminated

    Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only.

    Recall: Z-1856-2008 · Initiated May 12, 2008

    Recall

    Recall Number
    Z-1856-2008
    Event Number
    48135
    Firm
    Telefelx Medical
    FEI Number
    3005747797
    Product Code
    GDG
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    May 12, 2008
    Posted
    September 4, 2008
    Terminated
    April 19, 2012
    Address
    2917 Weck Drive, Durham, NC, 27709

    Description

    Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only.

    Reason

    The bands are breaking within the sealed packaging or in use prior to the expiration dates.

    Action

    Consignees were notified by letter via UPS next day, on/about 05/12/2008. They were instructed to return all affected product or acknowledge that the product no longer exists. They were further instructed to forward the letter to if they have further distributed the affected lots into institutional settings or to homecare patients and retrieve relevant product from those locations. If you require additional information or clarification regarding this matter, please contact Jackie Warner at 1-800-334-9751, ext. 4973.

    Distribution

    U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands

    Quantity

    5763 units