China NMPA Product Recall - Continuous blood purification equipment and devices

Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its continuous blood purification equipment and devices, as reported by the National Medical Products Administration (NMPA) on November 27, 2019. The recall was prompted by customer reports of communication error alarms, occurring at a rate of 1.4 per 1000 treatment protocols globally. These technical malfunctions led to three reported adverse events in overseas markets. In these instances, clinicians did not promptly follow on-screen instructions to return blood to patients after an alarm, resulting in patients experiencing serious symptoms such as anemia and hypotension, which required medical intervention. The action, overseen by the Shanghai Municipal Drug Administration, underscores a commitment to addressing product performance issues that could impact patient safety. Detailed information regarding the affected product models, specifications, and batches is provided in the associated "Medical Device Recall Event Report Form" to facilitate proper management of the recall.