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

On April 10, 2021, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its continuously circulating blood purification devices and associated equipment. This action, reported through the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses two critical issues. The first concern involves potential operational alarms, such as "calcium infusion tubing not connected," if non-Baxter-compatible calcium infusion tubing is used for "citric acid-injector pump calcium infusion" anticoagulation. Users are directed to strictly follow the Prismaflex operating manual for proper connections. The second issue highlights a discrepancy where the PrismaLung function, found enabled on some user machines, is not described in the user manual distributed in China, indicating a significant documentation gap regarding an active device feature. The recall encompasses specific models, specifications, and batches, with details provided in the Medical Device Recall Event Report Form, underscoring the company's commitment to ensuring device safety and regulatory compliance.