BEUDAMED
    FDA Recall Terminated

    Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.

    Recall: Z-1371-2008 · Initiated February 11, 2008

    Recall

    Recall Number
    Z-1371-2008
    Event Number
    46771
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 11, 2008
    Posted
    August 19, 2008
    Terminated
    March 16, 2012
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062

    Description

    Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.

    Reason

    Flush solution from TPN compounder may be added to patient's TPN bag.

    Action

    Consignees were notified by letter (Exacta-Mix Compounder Software Safety Alert) on 02/11/2008 advising them of the necessity to install a waste bag prior to a machine flush.

    Distribution

    Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand.

    Quantity

    221 units