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Z-2140-2012 Class I Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA device recall Z-2140-2012 was initiated by Baxter Healthcare Corp. on Jul 13, 2012 and is designated Class I. 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… The recall status is terminated (terminated Aug 11, 2017). Affected quantity: 840 units.

Recall Details

Product Type: Devices
Report Date: Aug 15, 2012
Initiation Date: Jul 13, 2012
Termination Date: Aug 11, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 840 units

Product Description

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.

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.

Distribution Pattern

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.

Code Information

Product code 2M8075, all serial numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2140-2012
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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