BEUDAMED
    FDA Recall 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 · Initiated March 13, 2012

    Recall

    Recall Number
    Z-0998-2013
    Event Number
    64609
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 13, 2012
    Posted
    March 26, 2013
    Terminated
    May 28, 2014
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    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.

    Action

    Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter informed the customers that ASP recently determined that the push bar located on the STERRAD 200 System Carriage can potentially become dislodged when an excessive load is applied. Customers with questions are instructed to contact Stericycle at (877) 931-0642.

    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