BEUDAMED
    FDA Recall Terminated

    Anestar and Anestar Plus Anesthesia System.

    Recall: Z-0929-06 · Initiated March 17, 2006

    Recall

    Recall Number
    Z-0929-06
    Event Number
    35059
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2006
    Posted
    June 2, 2006
    Terminated
    August 1, 2006
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Anestar and Anestar Plus Anesthesia System.

    Reason

    The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.

    Action

    Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required.

    Distribution

    The units have been distributed to distributors and end-users such as hospitals and clinics nationwide. There are 3 foreign accounts in Australia, El Salvador, and Venezuela.

    Quantity

    337 UNITS