Recall Z-2140-2012— Baxter Healthcare Corp.

Class I FDA medical device recall by Baxter Healthcare Corp., initiated 2012-07-13, terminated 2017-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm

Baxter Healthcare Corp.

Classification

Class I

Status

Terminated

Initiated

2012-07-13

Terminated

2017-08-11

Firm location

Round Lake, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.