Z-1386-2011

AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders...

Name: Z-1386-2011 AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders...
Creator: Baxter Healthcare Corp.
Published: 2011-01-27
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-01-27 / Terminated / root cause: software

FDA source

Baxter Healthcare Corp. began a recall of AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition... on 2011-01-27. The reason FDA records is "The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order...". 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-1386-2011
Status: Terminated
Initiated: 2011-01-27
Posted: 2011-02-22
Terminated: 2012-02-16
Recalling firm: Baxter Healthcare Corporation
Product: AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 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: LHI Set, I.V. Fluid Transfer
Reason for recall: The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from host software (MAN ID Mode). It is possible that an incorrect volume and/or an incorrect solution could be admixed into the final bag.
Root cause tag: software
FDA root cause: Other
Action: Baxter Healthcare Corp. sent Urgent Device Correction letters dated January 27, 2011, via first class mail to all affected customers. informing personnel that use Automix compounders to exercise care when entering data, and verify the accuracy of the keypad response. The accounts were requested to convey this information to all users of the Automix compounders, emphasizing the need to verify data accuracy each time the keypad is used. The accounts 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. After determining the root cause of the incorrect keypad responses, Baxter issued a follow-up correction letter on 4/27/11 outlining the recommended work practices to reduce fluid penetration into the Automix compounder keypad/control module.
Quantity in commerce: 950 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 codes 2M8287, all serial numbers

Product code LHI

K961008Class IIAutomix 3+3/As Compounder SystemBaxter Healthcare Corp / cleared 1997-10-10

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)