BEUDAMED
    FDA Recall Terminated

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    Recall: Z-0520-2013 · Initiated October 3, 2012

    Recall

    Recall Number
    Z-0520-2013
    Event Number
    63758
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    FRC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 3, 2012
    Posted
    December 12, 2012
    Terminated
    July 19, 2013
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    Reason

    Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.

    Action

    Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated November 2, 2012 to all customers who received the Sterrad Cyclesure 24 Biological Indicator (BI) product P/N 14324 manufactured between February 2008 and December 2011. The letter informed the customers of the problem identified and the actions to be taken. ASP determined that the 24 BI may not have adequate data to support the entire duration of the labeled shelf life of affected product manufactured during the above timeframe. The letter also informed customers that this is a different recall from the previous July 3, 2012 STERRAD CYCLESURE 24 BI recall. Customers with questions or need additional packing labels are instructed to call Stericycle at (877) 650-7692.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of AR, AU, BE, BR, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, VE, and RU.

    Quantity

    38,532 units