China NMPA Product Recall - Hemodialysis machine

On January 13, 2017, Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for certain hemodialyzers, a medical device manufactured by Bellco S.i.l. This action was reported to the National Medical Products Administration (NMPA) of China. The core issue stemmed from an inaccuracy in the registration certificate number printed on the Chinese labels of the affected products, specifically model BLS816SD, batch number LOT.1609000117. A total of 3360 units were identified as impacted, having been distributed across regions including Suzhou, Shanghai, and Guangzhou. To rectify this labeling non-compliance, Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. implemented a clear corrective action plan. This plan mandated that relevant sales teams and distributors issue formal notification letters to customers. Following this, customers and distributors were instructed to return all incorrectly labeled hemodialyzers. The final step involved the company's warehouse replacing the returned products with new dialyzers that featured accurate and compliant Chinese labeling, thereby addressing the regulatory requirements under the NMPA's oversight.