BEUDAMED
    FDA Recall Terminated

    Exacta-Mix 2400 pharmacy compounding system.

    Recall: Z-0210-04 · Initiated November 7, 2003

    Recall

    Recall Number
    Z-0210-04
    Event Number
    27695
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2003
    Posted
    July 20, 2004
    Terminated
    February 24, 2004
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062

    Description

    Exacta-Mix 2400 pharmacy compounding system.

    Reason

    If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber..

    Action

    All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.

    Distribution

    Nationwide. Foreign distribution to UK. No government or military consignees.

    Quantity

    231 systems