BEUDAMED
    FDA Recall Terminated

    QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. The QFC1631 is for Fujinon 450/485 Series Video Gastroscopes; The QFC1683 is for Fujinon EC-450LP Colonoscopes; The QFC1685 is for Fujinon 450/485 Series Video Colonoscopes with Water Jet;

    Recall: Z-0724-03 · Initiated March 20, 2003

    Recall

    Recall Number
    Z-0724-03
    Event Number
    25946
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2003
    Posted
    April 16, 2003
    Terminated
    February 5, 2004
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. The QFC1631 is for Fujinon 450/485 Series Video Gastroscopes; The QFC1683 is for Fujinon EC-450LP Colonoscopes; The QFC1685 is for Fujinon 450/485 Series Video Colonoscopes with Water Jet;

    Reason

    The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.

    Action

    The firm contacted their affected consignees by telephone and letter on 3/20/2003.

    Distribution

    The devices were shipped to hospitals located in ME, NB, CA, IL, NJ, OH, IL, TX, MA, GA, MO, NC, and FL.

    Quantity

    46