BEUDAMED
    FDA Enforcement Class II Terminated

    Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.

    Recall: Z-1829-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1829-2013
    Event ID
    65473
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steritec Products Mfc. Co., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    June 10, 2013
    Classification Date
    July 29, 2013
    Termination Date
    December 19, 2013
    Address
    74 Inverness Drive East, N/A, Englewood, CO, 80112-5114, United States

    Description

    Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.

    Reason

    Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.

    Code Info

    Affected Biological Indicator Lot No.:130401

    Distribution

    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.

    Quantity

    360 units