BEUDAMED
    FDA Recall Terminated

    QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680

    Recall: Z-0765-04 · Initiated March 15, 2004

    Recall

    Recall Number
    Z-0765-04
    Event Number
    28569
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    MED
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 15, 2004
    Posted
    July 20, 2004
    Terminated
    May 18, 2004
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680

    Reason

    A defective port adapter may affect the sterilization process of the attached endoscope.

    Action

    The firm contacted the consignees by letter and in person.

    Distribution

    The product was shipped to domestic consignees in LA, NC, OH, CT, VA, CA, ME, MD, IL, PA, SC, WY, ND, NY, OK, TX. Foreign distribution involves: Canada, Italy, and Germany.

    Quantity

    40 units