BEUDAMED
    FDA Recall Terminated

    Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube

    Recall: Z-0978-04 · Initiated April 30, 2004

    Recall

    Recall Number
    Z-0978-04
    Event Number
    29037
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 30, 2004
    Posted
    July 20, 2004
    Terminated
    August 12, 2004
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062

    Description

    Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube

    Reason

    A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

    Action

    Consignees were notified by phone, fax and letter beginning 4/30/2004.

    Distribution

    Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Venezuela.

    Quantity

    50 cases (10 per case)