BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2284-2012 · Initiated August 10, 2012

    Recall

    Recall Number
    Z-2284-2012
    Event Number
    62776
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    MED
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 10, 2012
    Posted
    August 28, 2012
    Terminated
    July 5, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    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..

    Action

    The firm, Steris, sent a "Voluntary Field Correction: Re-labeling of QKC1692E" letter on August 10, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter to re-label the affected QKC1692E(s) and return the completed form by September 30. 2012 to: Regulatory Affairs Specialist via [email protected] or via fax at (440) 350-7082. If you have any questions, contact Director, Regulatory Affairs at 440-392-7519.

    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