FDA: Class I recall of Alaris Infusion Pump System and Modules

Editor's Note

The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious.

The recall was initiated because of multiple system errors, software errors, and use-related errors. The errors can lead to delay in infusion, interruption of infusion, under-infusion, and over-infusion.

To date, there have been 55 reported injuries and one death.

Distribution dates were July 2004 to October 31, 2019, for unites with software version 9.33 and older and December 18, 2019 to January 23, 2020, for units with software version 12.1.0.