BEUDAMED
    FDA Enforcement Class III Terminated

    Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.

    Recall: Z-1736-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1736-2022
    Event ID
    90763
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation Hopkins Facility
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    August 10, 2022
    Classification Date
    September 9, 2022
    Termination Date
    October 30, 2024
    Address
    6515 Hopkins Rd, Mentor, OH, 44060-4307, United States

    Description

    Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.

    Reason

    Product contains incorrect chemical indicators in packaging.

    Code Info

    UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A

    Distribution

    Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY

    Quantity

    619 boxes