BEUDAMED
    FDA Recall Terminated

    STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.

    Recall: Z-0661-2013 · Initiated September 20, 2012

    Recall

    Recall Number
    Z-0661-2013
    Event Number
    63877
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 20, 2012
    Posted
    January 9, 2013
    Terminated
    October 17, 2013
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.

    Reason

    Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.

    Action

    Advanced Sterilization Product sent an Urgent Medical Device Recall (Removal) letter dated December 4, 2012, to all affected customers. The letter informed the customers that the Sterrad NX Cassettes do not have adequate data to support the entire duration of the product's labeled shelf-life. Customers are instructed of the problems identifed and the actions to be taken. Customers are instructed to notify their customers if they have further distributed the recalled products and to have them contact Stericycle at (877) 650-7686 to arrange for return of the product. Customers with questions are instructed to call Stericycle at (877) 650-7686 Mon-Fri from 8am to 5pm, ET. For questions regarding this recall call 949-453-6400.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.

    Quantity

    12,280 units