BEUDAMED
    FDA Recall Terminated

    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    Recall: Z-1180-2013 · Initiated April 22, 2013

    Recall

    Recall Number
    Z-1180-2013
    Event Number
    64972
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    FRC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2013
    Posted
    April 26, 2013
    Terminated
    August 1, 2013
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    Reason

    Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.

    Action

    Advanced Sterilization Products sent an Urgent Medical Device Recall letter dated April 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that have installed and validated STERRAD system between Feb 2012 and March 2013, are instructed to contact Stericycle at (888) 943-4901 to determine if their STERRAD System is eligible for an optional revalidation. If customers would like to have their system validation repeated, ASP will revalidate their system without charge. Customers are instructed that the revalidation can occur as part of a routine Planned Maintenance (PM) within 12 months. Customers are also notified that the optional procedure will require that their Sterrad System will be unavailable for use for approximately 31 hours (depending on their system) while revalidation is performed. Customers are instructed to contact Stericycle at the number above with their STERRAD System serial number by May 31 2013. Customers are instructed to contact Stericycle at (888) 943-4898 or contact their ASP representative. Stericycle's hours of operations are Mon-Fri , 8am-5pm, ET.

    Distribution

    Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN.

    Quantity

    69,994 cases