BEUDAMED
    FDA Enforcement Class II Terminated

    STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    Recall: Z-1027-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1027-2013
    Event ID
    64692
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Sterilization Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    March 22, 2013
    Classification Date
    March 29, 2013
    Termination Date
    September 30, 2013
    Address
    33 Technology Dr, N/A, Irvine, CA, 92618-2346, United States

    Description

    STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    Reason

    The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

    Code Info

    Codes: 10217 10201-002 10201 10202-001

    Distribution

    US Nationwide Distribution

    Quantity

    1038 units