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.
Published August 15, 2012 · Recall initiated: July 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- 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.
- Lot
- Product code 2M8075, all serial numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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