China NMPA Product Recall - Hemodialysis machine

Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class 1 recall of specific hemodialyzers due to an incorrect registration certificate number on the Chinese label. The issue, identified for products including Model BLS816SD, Batch LOT.160900011, led to the company reporting the incident to the National Medical Products Administration (NMPA) on January 13, 2017, with the recall details publicly accessible from March 27, 2017. The main violation centers on a labeling inaccuracy rather than a direct product performance or safety defect. Hemodialyzers are critical devices used for blood filtration and correcting electrolyte imbalances, emphasizing the importance of accurate regulatory information. As part of the corrective actions, Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. required its sales teams and distributors to issue notification letters to all affected customers. Customers and distributors were instructed to return the impacted batch of dialyzers. Furthermore, the company’s warehouse was tasked with holding the recalled products to prevent further distribution. This proactive recall demonstrates the company's commitment to regulatory compliance and product integrity within the medical device sector overseen by the NMPA.