BEUDAMED
    FDA Recall Terminated

    VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.

    Recall: Z-0605-2014 · Initiated September 10, 2013

    Recall

    Recall Number
    Z-0605-2014
    Event Number
    67036
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FRC
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    September 10, 2013
    Posted
    December 28, 2013
    Terminated
    February 14, 2014
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.

    Reason

    STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.

    Action

    On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY, and the countries of BAHRAIN, CANADA, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and THE NETHERLANDS.

    Quantity

    1,238 boxes