Baxter Healthcare Corp.: AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), 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.

Recall number

Z-2141-2012

Recalling firm

Baxter Healthcare Corp.

Product

AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), 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.

Status

Terminated

Initiated

2012-07-13

Posted

2012-08-08

Terminated

2017-08-11

Reason

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

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

3106 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.

Lot, serial or model codes

Product codes 2M8286 and 2M8286K, all serial numbers

510(k) numbers

not on file

PMA numbers

not on file

Product code

NEP

Firm FEI

1416980

Firm city

Round Lake

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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