BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0394-05 · Initiated December 20, 2004

    Recall

    Recall Number
    Z-0394-05
    Event Number
    30714
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2004
    Posted
    January 13, 2005
    Terminated
    May 19, 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

    Logix-CM software version 3.0.4 has not completed its official release process.

    Action

    Urgent Product Recall letters dated 12/20/04 were sent to the end users via overnight mail. The accounts were informed that software version 3.0.4 has not been officially released and must be removed from their compounders. They 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 remove Logix-CM software version 3.0.4 from their compounder and revert the software back to the configuration prior to Logix-CM 3.0.4 placement. Any questions were directed to Baxter Clintec Nutrition, option 1, at 1-800-422-2751.

    Distribution

    Arizona, Utah, North Carolina, Wisconsin and California.

    Quantity

    5 units