Z-2140-2012Class I

AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders

Name: Z-2140-2012 AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders
Creator: Baxter Healthcare Corp.
Published: 2012-07-13
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2012-07-13 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical... on 2012-07-13. FDA classified it as Class I and gives the reason as "After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2140-2012
Classification: Class I
Status: Terminated
Initiated: 2012-07-13
Posted: 2012-08-08
Terminated: 2017-08-11
Recalling firm: Baxter Healthcare Corporation
Product: AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter Healthcare Corp. sent an Urgent Product Recall letters dated July 13, 2012, via first class mail to all affected customers, informing personnel that Baxter was executing a voluntary controlled product withdrawal of the Automix system from the U.S. market by June 1, 2013. Until their units can be replaced, customers were advised to exercise care when entering data, and verify the accuracy of the keypad response; to inspect the umbilical cable of the Automix for any visible cuts, nicks deformation, or physical damage to the cable, discontinuing use of the device if such damage is found; and to return the device to Baxter if the device stops compounding without an alarm and without a visible green complete light, discarding the solution bag. The customers were requested to convey this information to all users of the Automix compounders, and a wall chart was provided to hang over the device to remind users of the mitigations to take. The customers were also requested to complete the attached customer reply form listing the model and serial number of each of the Automix compounders at the facility and confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to their local Baxter representative, and technical questions were directed to Baxter's Global Technical Services at 1-800-626-2667.
Quantity in commerce: 840 units
Distribution: Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom.
Product codes and lots: Product code 2M8075, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2140-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2139-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08
Z-2140-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08
Z-2141-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08
Z-2142-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

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)