BEUDAMED
    FDA Recall Terminated

    ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.

    Recall: Z-0945-2007 · Initiated April 16, 2007

    Recall

    Recall Number
    Z-0945-2007
    Event Number
    37905
    Firm
    Conmed Endoscopic Technologies, Inc.
    FEI Number
    1000159712
    Product Code
    KNQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 16, 2007
    Posted
    June 19, 2007
    Terminated
    July 30, 2010
    Address
    129 Concord Rd, Bldg 3, Billerica, MA, 01821-4600

    Description

    ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.

    Reason

    Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

    Action

    Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning product.

    Distribution

    Worldwide-Devices distributed to medical facilities and distributors Nationwide (USA) and to distributors in the following countries: Australia, Belgium, Canada, Croatia, Denmark, Germany, India, Italy, Japan, Mexico, Poland, Spain and Sweden.

    Quantity

    452 units.