Z-1752-2013Class II

ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile...

Name: Z-1752-2013 ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile...
Creator: Baxa Corporation
Published: 2013-06-04
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2013-06-04 / Terminated / root cause: manufacturing process

FDA source

Baxa Corporation began a recall of ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution on 2013-06-04. FDA classified it as Class II and gives the reason as "Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1752-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-04
Posted: 2013-07-18
Terminated: 2015-10-16
Recalling firm: Baxter Corporation Englewood
Product: ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 6/04/13, customers were notified by 1st class mailing with mitigating instructions including reminding customers that the battery failure results in a failure of the ExactaMix system to alert the user to replace the disposable set after 24 hours of use. Users should not rely on the alert to trigger the daily replacement of disposable sets. Users should also confirm the correct time and date at the setup of each use. If the compounder displays an incorrect time and date, customers are to contact Baxter Technical Support.
Quantity in commerce: 753 units
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Product codes and lots: ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1752-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1752-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-18

Product code LHI

K002705Class IIExacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. / cleared 2001-03-28

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)