BEUDAMED
    FDA Enforcement Class II Terminated

    STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

    Recall: Z-0998-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0998-2013
    Event ID
    64609
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Sterilization Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    March 13, 2012
    Classification Date
    March 26, 2013
    Termination Date
    May 28, 2014
    Address
    33 Technology Dr, Irvine, CA, 92618-2346, United States

    Description

    STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

    Reason

    Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.

    Quantity

    2,457 units