BEUDAMED
    FDA Recall Terminated

    Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    Recall: Z-1773-2012 · Initiated February 17, 2012

    Recall

    Recall Number
    Z-1773-2012
    Event Number
    61954
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    FRC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 17, 2012
    Posted
    June 6, 2012
    Terminated
    October 17, 2013
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    Reason

    The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator.

    Action

    Advanced Sterilization Products a Johnson & Johnson company sent an Urgent Product Recall letter dated March 16, 2012, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to read the "Details on the Affected Devices/Description of the problem" section in the letter. Customers were instructed to immediately identify and set aside all product listed above in a manner that ensures product will not be used. The lot number and the part number are printed on the label placed around the ampoules. Customers were instructed to return any affected product in accordance with the "Product Return Instructions" section of the letter. Customers were instructed to complete the requested information on the enclosed postage paid business reply card and return it to Stericycle even if they do not have the affected products listed on the letter in stock. Customers with questions were instructed to contact Stericycle at (877) 492-4795. For questions regarding this recall call 949-453-6400.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of AR, AU, BE, BR, CA, EC, HK, JP, MX, and PR

    Quantity

    2,284 cases (137,040 Biological Indicators)