Dangerous Endotoxins Lead To Class I Recall For Medtronic Device Used On Pediatric Patients
Executive Summary
The US FDA on 24 March gave its highest risk designation to a recall of the company’s Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir. The device is used on newborns, infants and small pediatric patients undergoing a cardiopulmonary bypass procedure.