03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), 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 codes 2M8286 and 2M8286K, 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
C l a s s I I
C l a s s I I I
C l a s s I
Enforcement Report - Week of August 15, 2012