BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1868-2013 · Initiated June 4, 2013

    Recall

    Recall Number
    Z-1868-2013
    Event Number
    65544
    Firm
    Mesa Laboratories, Inc., Bozeman Manufacturing Facility
    FEI Number
    3013667284
    Product Code
    FRC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 4, 2013
    Posted
    August 1, 2013
    Terminated
    November 22, 2013
    Address
    10 Evergreen Dr, Ste E, Bozeman, MT, 59715-2457

    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.

    Action

    Mesa Labs sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions contact Mesa Labs at [email protected].

    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