03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [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. [Code Info] Product code 2M8075, all serial numbers [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. [Recalling Firm] Baxter Healthcare Corp. [Classification] 
Class I
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C l a s s I
Enforcement Report - Week of August 15, 2012