Baxter Healthcare Corp.: Medical Device Recall in 2012 - (Recall #: Z-2139-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

AUTOMIX High Speed Compounder System, product 2M8077; 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 Classification:

Class I

Date Initiated: July 13, 2012

Date Posted: August 15, 2012

Recall Number: Z-2139-2012

Event ID: 62558

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.

Status: Terminated

Product Quantity: 270 units

Code Information:

Product code 2M8077, all serial numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated