BEUDAMED
    FDA Recall Terminated

    Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.

    Recall: Z-0277-2016 · Initiated October 14, 2015

    Recall

    Recall Number
    Z-0277-2016
    Event Number
    72418
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GBW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 14, 2015
    Terminated
    December 11, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.

    Reason

    The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.

    Action

    Recall letters were sent to customers and distributors. The letter requested that the accounts discontinue use and quarantine for return any product. The distributors were requested to conduct a sub-recall. The letters included a Recall Acknowledgement Form which was to be returned to Teleflex.

    Distribution

    Nationwide Distribution including the states of AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI.

    Quantity

    2050 ea.