BEUDAMED
    FDA Recall Terminated

    Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.

    Recall: Z-1436-2012 · Initiated January 19, 2009

    Recall

    Recall Number
    Z-1436-2012
    Event Number
    52013
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 19, 2009
    Posted
    May 25, 2012
    Terminated
    September 12, 2012
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.

    Reason

    Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.

    Action

    Baxa Corporation sent a "Safety Alert" letter dated January 19, 2009 via FedEx to all affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to ensure that users create either a salt-based template OR an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were provided a list of safe practices to follow on the enclosed ISMP Safety Alert. Customers were advised upon receipt of the Safety Alert that Baxa Technical Support will review and address any issues with the customer on their configuration setup for calcium and magnesium. For questions contact Baxa Technical Support at 1-800-678-2292.

    Distribution

    Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.

    Quantity

    667 units