BEUDAMED
    FDA Recall Terminated

    Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S

    Recall: Z-0197-06 · Initiated September 16, 2005

    Recall

    Recall Number
    Z-0197-06
    Event Number
    33513
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 16, 2005
    Posted
    November 24, 2005
    Terminated
    November 21, 2011
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S

    Reason

    The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load.

    Action

    The recall strategy consists of supplying each customer of the STERRAD 100 and the STERRAD 1OOS with: a notification letter of the field action (mailed 09/22/05 ), a pack containing two vaporizer plates of the newly released design, and a set of instructions for self-installation.

    Distribution

    Nationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.

    Quantity

    5365