BEUDAMED
    FDA Recall Terminated

    Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.

    Recall: Z-0677-2012 · Initiated December 6, 2011

    Recall

    Recall Number
    Z-0677-2012
    Event Number
    60619
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GDG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 6, 2011
    Posted
    January 11, 2012
    Terminated
    May 20, 2014
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709

    Description

    Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.

    Reason

    Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.

    Action

    The firm, Teleflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 6, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine any products with the listed catalog and lot numbers; communicate this recall to any of their customers who have received the product; have their customers return the affected product together with a completed Recall Acknowledgement Form to Teleflex Medical, if an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990; complete and return the Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customers Service even if they and their customers have no affected stock. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Nationwide distribution.

    Quantity

    to be obtained