Airway product recalls weigh down on CareFusion and Smiths
This article was originally published in Clinica
Executive Summary
The US FDA has given CareFusion's recall of its Avea ventilator the most serious classification. The company initiated the Class I action in September when it discovered a potential defect in the ventilator that could cause it to activate a false alarm and stop ventilating, which, in turn, could lead to patient injury or death if left unnoticed. Devices affected by the recall were manufactured between 1 March 2009 and 30 June 2011.