China NMPA Product Recall - Membrane plasma separator

Asahi Kasei Medical Systems 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. Publicly announced on October 30, 2017, the recall was prompted by a labeling discrepancy identified after the product's approval renewal on January 13, 2017. The core issue was that product labels for batch number AG2B2N mistakenly displayed the old registration certificate number instead of the new National Medical Device Registration Certificate 20173450240. This regulatory non-conformance affected 426 imported units, with 300 having been sold in China. Operating under the National Medical Products Administration (NMPA) framework, the company confirmed that this recall was due to an administrative error and presented no risk to product quality or patient safety, thus units already sold or in use were deemed safe. Required actions included: distributing recall notices to all distributors, instructing them to cease sales and return all affected products, providing sales information, and ultimately destroying the recalled inventory. This measure ensures adherence to regulatory labeling standards within the Chinese market.