China NMPA Product Recall - MICROPLAS MPS Plasma Separator

Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd., also known as Bellco, has initiated a voluntary Class II recall of its MICROPLAS MPS Plasma Separators. This action, publicly announced on February 21, 2020, follows reports of serious patient impact due to product misuse. The core issue stems from healthcare professionals incorrectly using the MICROPLAS MPS plasma separator in place of the AQUAMAX HF blood filter during continuous renal replacement therapy (CVVHDF treatment). Two specific incidents highlighted this critical error: one reported in March 2018 and another similar occurrence in October 2019. The company identified user error in selecting the wrong medical device as the root cause. Under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration (SFDA), Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. is undertaking this recall. The recall specifically targets plasma separators with registration certificate numbers CFDA (Imported) No. 20133450555 (revised) and CFDA Import Registration No. 20163454896. Detailed product models, specifications, and batches are provided in an accompanying Medical Device Recall Event Report Form. This recall emphasizes the importance of correct product identification and usage in medical procedures to ensure patient safety.