BEUDAMED
    FDA Recall Terminated

    Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073

    Recall: Z-0392-05 · Initiated December 8, 2004

    Recall

    Recall Number
    Z-0392-05
    Event Number
    30609
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 8, 2004
    Posted
    December 30, 2004
    Terminated
    November 1, 2005
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073

    Reason

    A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software.

    Action

    Urgent Device Correction letters dated 12/8/04 were sent to the end users via overnight mail. The accounts were informed of the potential for omission of an ingredient if there are duplicate drug Id''s in the order, and were requested to complete and fax the customer reply form to Baxter at 847-270-5457, indicating if they are currently using Logix-CM software. Upon receipt of the reply form, Baxter will schedule a visit to the facility to examine the base and additive inventory information in their MOS database to confirm that there are no duplicate Drug ID numbers and that this issue has not occurred at the facility. They will also secure the MOS database to ensure that the situation will not be able to occur. Any questions were directed to Baxter Clintec Nutrition, option 1, at 1-800-422-2751.

    Distribution

    Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada

    Quantity

    12 units