BEUDAMED
    FDA Recall Terminated

    STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Recall: Z-0043-2014 · Initiated September 18, 2013

    Recall

    Recall Number
    Z-0043-2014
    Event Number
    66328
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 18, 2013
    Posted
    October 22, 2013
    Terminated
    April 11, 2014
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization 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 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

    Action

    A customer notification letter was sent on September 18, 2013, to all customers who received the STERRAD 200 Sterilization System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to indicate if they have received a STERRAD 200 System and to report any complaints or suspected problems to Advanced Sterilization Products (ASP) Professional Services directly at (888) 783-7723 and select option #2. An alternate design for the oil mist filter is being developed and qualification of new vacuum pump oil is in process. This action is to modify the PM interval to service the filter and oil more frequently. This will serve as an immediate/interim solution to reduce incidence of odor/smell complaints until the new oil mist filter design and vacuum pump oil are released. A Customer Letter will be sent to all STERRAD 200 customers to notify them of the issue and the corrective actions we are taking to resolve this issue.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada

    Quantity

    1,305 units total (654 units in US , 651 OUS )