FDA And Edwards Lifesciences Issue Class I Recall Of Hemodialysis System

Bookmark and Share

[Posted 01/28/2010] FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.

MORE ON THIS TOPIC