China NMPA Product Recall - Ventilator (Model: AVEA)

CareFusion Shanghai Trading Co., Ltd. initiated a Level I voluntary recall for its AVEA ventilators following the discovery of a critical pressure sensor defect. This defect, reported to the National Medical Products Administration (NMPA) on May 14, 2015, and publicly announced on May 22, 2015, poses a serious risk as it can cause the ventilator to cease air supply. The malfunction may also trigger false "Extended High Pressure" or "Circuit Occlusion" alarms, potentially delaying the start of ventilation. While the device's safety valve opens to allow spontaneous breathing if an alarm occurs and ventilation stops, the issue still represents a significant operational failure for life-supporting equipment. The recall impacts 703 AVEA ventilator units imported into China, with 681 already sold, identified by specific serial numbers including AHV, AJV, AKV, BAV, BBV, BCV, BDV, and BEV. Globally, these devices are intended for continuous respiratory support in formal healthcare settings for adults, children, and newborns. Under the NMPA's regulatory framework for medical device recalls, CareFusion is taking immediate action. They are instructing customers to discontinue use of affected ventilators and switch to alternative devices if alarms persist and cannot be resolved by standard troubleshooting. Furthermore, CareFusion will supply necessary repair parts to replace faulty components in all affected units, ensuring the safety and functionality of the devices.