BEUDAMED
    FDA Enforcement Class II Terminated

    STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

    Recall: Z-0746-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0746-2014
    Event ID
    67043
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Sterilization Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    December 16, 2013
    Classification Date
    January 14, 2014
    Termination Date
    March 27, 2014
    Address
    33 Technology Dr, Irvine, CA, 92618-2346, United States

    Description

    STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

    Reason

    Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

    Code Info

    not available

    Distribution

    Nationwide Distribution

    Quantity

    2366 units