China NMPA Product Recall - Hemodialysis machine

Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its hemodialyzers in December 2018. This action followed a medical device sampling inspection where in vitro test results indicated a critical deviation: the measured value of vitamin B12 in the devices exceeded the acceptable tolerance range of ±10%. The recall, referenced as [Shanghai Food and Drug Administration Medical Device Recall 2018-290], was formally reported by the company to the National Medical Products Administration (NMPA). The affected products, specifically hemodialyzers with Registration Certificate No.: 20143455643, required immediate attention due to this quality control issue. The company's proactive voluntary recall demonstrates adherence to medical device safety standards under the oversight of regulatory bodies like the NMPA. Details concerning the specific models, specifications, and batch numbers of the impacted hemodialyzers were provided in a Medical Device Recall Event Report Form, ensuring comprehensive management of the recall process. This incident highlights the importance of stringent quality control in medical device manufacturing to ensure patient safety and product efficacy.