BEUDAMED
    FDA Recall Terminated

    Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.

    Recall: Z-1238-2007 · Initiated June 27, 2007

    Recall

    Recall Number
    Z-1238-2007
    Event Number
    38372
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2007
    Posted
    September 27, 2007
    Terminated
    December 7, 2007
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062

    Description

    Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.

    Reason

    A software defect could allow up to 50mL of extra volume being added to a TPN solution.

    Action

    All customers were notified via telephone on 06/27/2007 with follow-up of a faxed/emailed Urgent Product Recall letter dated 27 June 2007, detailing the software defect. End users were given a work around procedure to use until conversion back to version 1.06 could be scheduled. An additional copy of the recall letter was sent by FedEx.

    Distribution

    Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK

    Quantity

    30 units