Z-1963-2014Class II

EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display...

Name: Z-1963-2014 EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display...
Creator: Baxter Healthcare Corp.
Published: 2014-06-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-06-10 / Terminated / root cause: software

FDA source

Baxter Healthcare Corp. began a recall of EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder... on 2014-06-10. FDA classified it as Class II and gives the reason as "If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining...". 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-1963-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-10
Posted: 2014-07-01
Terminated: 2017-02-22
Recalling firm: Baxter Healthcare Corporation
Product: EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Device Correction communication via 1st class mail was mailed on July 14, 2014, informing customers of a potential issue if the universal ingredient in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual.
Quantity in commerce: 1758
Distribution: US Nationwide
Product codes and lots: model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1963-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1963-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)