Z-1640-2008

Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version...

Name: Z-1640-2008 Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version...
Creator: Baxter Healthcare Corp.
Published: 2008-03-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2008-03-28 / Terminated / root cause: software

FDA source

Baxter Healthcare Corp. began a recall of Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM)... on 2008-03-28. The reason FDA records is "Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly". 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-1640-2008
Status: Terminated
Initiated: 2008-03-28
Posted: 2008-08-24
Terminated: 2008-08-25
Recalling firm: Baxter Healthcare Corporation
Product: Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.
Root cause tag: software
FDA root cause: Software design
Action: Baxter sent the 3/28/08 Urgent Device Correction letter to affected customers, to the attention of the Director of Pharmacy, via first class mail to advise them of the potential inaccuracy of the Delivery Report due to a software anomaly. The accounts were instructed to review each delivery report for accuracy. If the report contains zero actual volumes the user must manually reprint the report. The letter outlined the process for reprinting the Delivery Report. Any questions were directed to the Baxter Nutritional Professional Services at 1-800-422-2751. The accounts were requested complete the enclosed reply form acknowledging receipt and understanding of the letter and dissemination of the information to their staff. A software upgrade will be provided. If you have questions about this letter or you did not receive this letter contact Baxter Nutrition Professional Services at 1-800-422-2751.
Quantity in commerce: 5 units
Distribution: Arizona, Minnesota, Wisconsin, Puerto Rico and Canada
Product codes and lots: Software version 1.0.2 (comprised of Logix OE version 1.0.28 and Logix CM version 3.1.8)

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)