BEUDAMED
    FDA Enforcement Class II Terminated

    QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.

    Recall: Z-2284-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2284-2012
    Event ID
    62776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    September 5, 2012
    Initiation Date
    August 10, 2012
    Classification Date
    August 28, 2012
    Termination Date
    July 5, 2013
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.

    Reason

    STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..

    Code Info

    Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190

    Distribution

    Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.

    Quantity

    64 units