China NMPA Product Recall - Membrane plasma separator

Asahi Kasei Medical Systems Co., Ltd., via its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., initiated a voluntary Class III recall of certain membrane plasma separators. This action, reported to the National Medical Products Administration (NMPA) and published on October 30, 2017, was due to a labeling error rather than product quality or safety concerns. The company identified that products with batch number AG2B2N, manufactured for the Chinese market, continued to display the old registration certificate number on their labels, despite the certificate being renewed with a new number (国械注进20173450240) on January 13, 2017. The recall involved 426 units produced, with 300 units sold in China. Under the NMPA's regulatory guidance, the company implemented several corrective actions: distributing recall notices to all distributors, instructing them to cease sales and return affected products, and requiring submission of sales information. It was clarified that products already sold or in use posed no safety risk. All recalled products were to be destroyed.