BEUDAMED
    FDA Recall Terminated

    STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Recall: Z-2174-2013 · Initiated July 25, 2013

    Recall

    Recall Number
    Z-2174-2013
    Event Number
    65957
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 25, 2013
    Posted
    September 10, 2013
    Terminated
    November 27, 2013
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Reason

    The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.

    Action

    ASP sent an Urgent Medical Device Field Safety Notification letter dated July 25, 2013, to all affected customers. The recall letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to contact Stericycle directly at (866) 562-5937 to report any complaints or suspected problems with their STERRAD 100NX System cassette. For questions regarding this recall call 949-453-6400.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela.

    Quantity

    1,923 units