BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0044-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0044-2014
    Event ID
    66317
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Sterilization Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    September 18, 2013
    Classification Date
    October 22, 2013
    Termination Date
    January 13, 2014
    Address
    33 Technology Dr, N/A, Irvine, CA, 92618-2346, United States

    Description

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

    Reason

    Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.

    Code Info

    Lot# 13F050, 13F051, 13F049

    Distribution

    Nationwide Distribution

    Quantity

    2,995 units