BEUDAMED
    FDA Enforcement Class II Terminated

    Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

    Recall: Z-1868-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1868-2013
    Event ID
    65544
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mesa Laboratories, Inc., Bozeman Manufacturing Facility
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2013
    Initiation Date
    June 4, 2013
    Classification Date
    August 1, 2013
    Termination Date
    November 22, 2013
    Address
    10 Evergreen Dr Ste E, N/A, Bozeman, MT, 59715-2457, United States

    Description

    Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

    Reason

    Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

    Code Info

    Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15. Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.

    Quantity

    2447/100 count boxes