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

Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall and issued a safety warning for its continuously circulating blood purification devices, including the Prismaflex machine. This action, publicized by the National Medical Products Administration (NMPA) in April and August 2020, addresses a significant patient safety concern. The issue arose when overseas doctors, treating COVID-19 patients, reportedly used extended tubing to connect the Prismaflex machine, aiming to minimize contact with infected individuals. However, this unauthorized modification carried inherent risks and had the potential to cause adverse patient events. To mitigate these dangers, Baxter is requiring all users to strictly adhere to the original setup instructions provided in the machine’s user interface and the official Prismaflex operating manual. The voluntary recall covers specific models and batches of the devices, identified under CFDA Import Registration Numbers 20113453455 and 20163451912. This regulatory measure, overseen by the NMPA and Shanghai Municipal Drug Administration, underscores the critical importance of operating medical devices precisely according to manufacturer guidelines to ensure patient safety and device efficacy.