China NMPA Product Recall - MICROPLAS MPS Plasma Separator

Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its MICROPLAS MPS Plasma Separators. This critical action, overseen by the National Medical Products Administration (NMPA) and reported by the Shanghai Municipal Drug Administration, was prompted by severe patient safety incidents. The company received two customer reports in March 2018, detailing instances where MICROPLAS plasma separators were mistakenly used instead of AQUAMAX blood filters during continuous renal replacement therapy, causing serious harm to patients. A subsequent, similar incident was reported in October 2019. These events highlighted a significant risk of product confusion and incorrect application. The voluntary recall aims to prevent further misuse and mitigate potential adverse impacts on patient health. The affected plasma separators were registered under CFDA (Imported) No. 20133450555 and CFDA Import Registration No. 20163454896. Specific batch information for the recalled products is detailed in an accompanying Medical Device Recall Event Report Form. The NMPA website officially published this recall on April 9, 2020.