China NMPA Product Recall - Ventilator (Model AVEA)

CareFusion (Shanghai) Trading Co., Ltd. initiated a recall for its AVEA model ventilators due to a malfunction in the inspiratory pressure sensor (GDE). This issue, affecting units manufactured between March 1, 2009, and June 30, 2011, causes false continuous peak pressure alarms, leading to the safety valve opening and ventilation interruption. If alternative ventilation is not promptly provided, this poses a risk of patient harm, though no deaths or serious injuries have been reported. The recall operates under the National Medical Products Administration (NMPA) framework, with regulatory guidance issued in December 2011. CareFusion's required actions include a proactive on-site correction to replace the faulty GDE component with a new one, performed by trained technicians. The company is identifying affected customers via sales records, halting further sales of recalled units, and notifying customers to coordinate the replacements. This corrective action, supported by CareFusion’s after-sales service agent, was expected to begin in late November 2011 and conclude by December 1, 2012.