BEUDAMED
    FDA Enforcement Class II Terminated

    Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.

    Recall: Z-1826-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1826-2013
    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

    Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.

    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.:121101-447 and 121101-444

    Distribution

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

    Quantity

    15,300 units