CareFusion initiated the recall last month, just 1 year after a different software issue resulted in another Class I warning from the FDA for the Alaris line.
The latest recall affects the model 8100 Alaris pump modules, which may fail to properly delay infusion when the "delay until" or "multidose" feature is selected. CareFusion has received a single report of such a failure, according to the FDA memo.
"Affected customers were informed that if the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician, serious injury or death could result," regulators said.
CareFusion recommended that users downgrade their software to a previous version in order to address the recall, saying that the company would contact all affected customers to schedule the installation.
Last year’s recall was launched over concerns in the 8105 models, which ran a version of the software that CareFusion said may display communication errors when attached to EtCO2 or SpO2 modules. The U.K. had warned CareFusion on its Alaris GP infusion pump earlier that same month. The Alaris GP infusion pump was also the subject of FDA warning letters and recalls in 2012.