BEUDAMED
    FDA Enforcement Class III Terminated

    TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.

    Recall: Z-2186-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2186-2012
    Event ID
    62598
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    July 20, 2012
    Classification Date
    August 10, 2012
    Termination Date
    February 12, 2015
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709, United States

    Description

    TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.

    Reason

    Product is missing the label on the internal packaging.

    Code Info

    Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.

    Distribution

    AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, MS, NC, NY, OH, PA, SD, TX, UT, VA, WI, WV.

    Quantity

    611 units