Z-0394-05

Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System...

Name: Z-0394-05 Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System...
Creator: Baxter Healthcare Corp.
Published: 2004-12-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2004-12-20 / Terminated / root cause: software

FDA source

Baxter Healthcare Corp. began a recall of Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073 on 2004-12-20. The reason FDA records is "Logix-CM software version 3.0.4 has not completed its official release process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0394-05
Status: Terminated
Initiated: 2004-12-20
Posted: 2005-01-13
Terminated: 2005-05-19
Recalling firm: Baxter Healthcare Corporation
Product: Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Logix-CM software version 3.0.4 has not completed its official release process.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 5 units
Distribution: Arizona, Utah, North Carolina, Wisconsin and California.
Product codes and lots: Software version 3.0.4

Product code LHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)