BEUDAMED
    FDA Recall Terminated

    Pilling Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA

    Recall: Z-0268-2008 · Initiated October 31, 2007

    Recall

    Recall Number
    Z-0268-2008
    Event Number
    45515
    Firm
    Telefelx Medical
    FEI Number
    3005747797
    Product Code
    HTD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 31, 2007
    Posted
    November 29, 2007
    Terminated
    August 31, 2009
    Address
    2917 Weck Drive, Durham, NC, 27709

    Description

    Pilling Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA

    Reason

    The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.

    Action

    Consignees were notified by an Urgent Medical Device Recall letter on/about 11/1/2007. They were instructed to immediately cease use and distribution of the affected product and to return them to Teleflex Medical, Durham, NC. In addition, each were instructed to forward the letter if they had further distribution into institutional settings or to homecare patients and retrieve relevant product form those locations. An Acknowledgement & Stock Status Form was enclosed to be completed and faxed back to Teleflex Medical.

    Distribution

    Worldwide: USA including states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, NV, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, France New Zealand and Singapore.

    Quantity

    113