BEUDAMED
    FDA Recall Terminated

    STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Recall: Z-0843-2015 · Initiated November 4, 2014

    Recall

    Recall Number
    Z-0843-2015
    Event Number
    69692
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    FLF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 4, 2014
    Posted
    December 22, 2014
    Terminated
    August 4, 2015
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    Reason

    Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

    Action

    A customer notification letter dated 11/21/2014 will be sent to all customers who purchased the STERRAD 50, STERRAD 100S, STERRAD 200, STERRAD 100NX, and STERRAD NX System Cassettes. The letter informs the customers of the problems identified and the actions to be taken.

    Distribution

    Worldwide Distribution.

    Quantity

    19,978 units total (9,792 units in US)