Z-1389-2012

Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both...

Name: Z-1389-2012 Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both...
Creator: Baxa Corporation
Published: 2009-03-23
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2009-03-23 / Terminated / root cause: software

FDA source

Baxa Corporation began a recall of Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities... on 2009-03-23. The reason FDA records is "Software issue with compounding pump resulting in over delivery of component ingredients during routine operations". 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-1389-2012
Status: Terminated
Initiated: 2009-03-23
Posted: 2012-04-09
Terminated: 2012-04-10
Recalling firm: Baxter Corporation Englewood
Product: Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
Root cause tag: software
FDA root cause: Software design
Action: Baxa sent a Safety Alert letter dated March 23, 2009 to all affected consignees. The letter identified the affected product, problem and recommended actions with specific instructions related to the issue. Additionally, the firm will be providing a warning label for the affected product as soon as possible and is currently working on a product upgrade to correct the issue. For assistance contact Baxa Technical Support at 800-678-2292. The firm is also providing a 24 hour a day, 7 days a week Technical Support for the affected product.
Quantity in commerce: 1322 units
Distribution: Worldwide Distribution - USA Nationwide including Canada.
Product codes and lots: 2 model numbers 2400 D and 2400 M.

Product code NEP

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)