BEUDAMED
    FDA Recall Terminated

    WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.

    Recall: Z-2584-2010 · Initiated July 30, 2010

    Recall

    Recall Number
    Z-2584-2010
    Event Number
    56379
    Firm
    Telefelx Medical
    FEI Number
    3005747797
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2010
    Posted
    September 27, 2010
    Terminated
    April 21, 2011
    Address
    2917 Weck Drive, Durham, NC, 27709

    Description

    WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.

    Reason

    Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes.

    Action

    Teleflex Medical sent an "Urgent Medical Device Recall" letter dated July 30, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to immediately discontinue use, quarantine any affected products and return all of the affected product to Teleflex Medical; forward the letter to their customers to retrieve product from those locations and complete and return the Recall Acknowledgement Form via fax at 1-866-804-9881. A second mailing to non-responding customers on the consignee list will be mailed approximately four to six seeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. Note: A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide distribution: USA and countries of Canada, Australia and Singapore.

    Quantity

    190,344 eaches