BEUDAMED
    FDA Enforcement Class II Terminated

    STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Recall: Z-0403-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0403-2014
    Event ID
    66815
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Sterilization Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    November 11, 2013
    Classification Date
    November 26, 2013
    Termination Date
    January 22, 2014
    Address
    33 Technology Dr, N/A, Irvine, CA, 92618-2346, United States

    Description

    STERRAD NX, Product Code: 10033 The STERRAD Steri lization 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 STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.

    Code Info

    Please refer to consignee list

    Distribution

    Nationwide Distribution

    Quantity

    Total 4,381 units