China NMPA Product Recall - Prismaflex system

Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Level 2 recall for its Prismaflex Continuous Blood Purification Equipment and related devices, as announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on February 24, 2021. The recall was prompted by an increasing trend of quality failures involving the pump tubing within the Prismaflex automatic reset system. This issue stems from performance degradation in the tubing, which can lead to alarms during the system's self-test or treatment. Repeated alarms pose a significant risk of treatment interruptions, potentially causing harm to patients. To address these critical safety concerns, Baxter is implementing a corrective action. This action includes the replacement of the affected pump tubing and a proactive recall of the devices to ensure patient safety and compliance with medical device regulations under the NMPA's framework.