China NMPA Product Recall - Acute dialysis and extracorporeal blood therapy machines

Fresenius Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its acute dialysis and extracorporeal blood therapy machines, published on August 21, 2019. This action followed findings from a national random inspection. The primary issue identified was that, in manual operation mode, the venous pressure low limit alarm on certain devices could be set to 0 mmHg. This setting deviates from Chinese industry standards, which require this alarm threshold to be no less than 10 mmHg.

While the company asserted that this discrepancy did not pose additional patient risk—as alarms would still activate if a patient's intravenous catheter disconnected or the venous pressure sensor failed, thereby not compromising product quality or safety—Fresenius Medical Products fully committed to adhering to national regulations. The recall demonstrates the company's cooperation with the requirements of Chinese industry standards and national sampling inspections, under the oversight of the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration. The recall affects several registered models, with detailed information available in an accompanying report.