China NMPA Product Recall - Continuous blood purification equipment; continuous blood purification device

Baxter Medical Products Trading (Shanghai) Co., Ltd. has initiated a voluntary Level II recall of its Continuous Blood Purification Equipment (Continuous Blood Purification Device). This action, published on March 8, 2021, and updated from the Shanghai Food and Drug Administration's (SFDA) Medical Device Recall 2020-001, addresses critical issues identified globally. The primary concern involves communication error alarms on the equipment. These alarms, when not promptly addressed by patients following on-screen instructions to return blood, have led to adverse health outcomes. Specifically, customer reports indicate that patients experienced symptoms such as anemia and low blood pressure due to the failure to return blood efficiently after an alarm. Under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, Baxter's required action is a software update for the affected devices. This update aims to mitigate the communication error alarms and prevent the associated patient risks. The voluntary recall underscores the company's commitment to patient safety and adherence to medical device regulations in China. This proactive measure ensures that the continuous blood purification equipment operates reliably, reducing potential harm to patients undergoing treatment.