China NMPA Product Recall - Membrane plasma separator

Asahi Kasei Medical Co., Ltd., through its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., initiated a voluntary Class III recall of its membrane plasma separators in China. The recall, indexed by the National Medical Products Administration (NMPA) as JGXX-2017-11017 on October 30, 2017, stemmed from a labeling discrepancy. Following the renewal of the product's approval on January 13, 2017, which resulted in a new certificate number ("国械注进20173450240"), the company discovered that products from batch number AG2B2N manufactured in February still bore the old registration number on their labels. The manufacturer explicitly stated that this recall is not related to the product's quality or safety. The primary issue was the incorrect regulatory identification on the packaging. As required by the NMPA framework for a Class III recall, Asahi Kasei Medical Systems Co., Ltd. mandated several corrective actions. These included issuing recall notices to distributors, instructing them to halt sales, and facilitating the return of affected units. Distributors were also required to provide sales data for the recalled products. Furthermore, the company decided that products already sold or in use did not pose a safety risk and planned for the destruction of all returned recalled items. This action ensures compliance with labeling regulations.