Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a Class I recall concerning the following products manufactured by Baxter Healthcare Corporation:

• AUTOMIX High Speed Compounder System (Product code 2M8077)
• AUTOMIX Plus High Speed Compounder System (Product code 2M8075)
• AUTOMIX 3+3 Compounder System 115V and 230V (Product code 2M8286 and 2M8286K)
• AUTOMIX 3+3 Compounder with Accusource Monitoring System (Product code 2M8287)

According to the FDA, 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. Besides, 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.

For details, please refer to FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62558&w=08152012&

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 August 2012