China NMPA Product Recall - Membrane plasma separator

Asahi Kasei Medical Systems Co., Ltd., in collaboration with its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., has initiated a voluntary Class III recall of its Membrane Plasma Separators. This recall, formally reported on October 24, 2017, and published by the National Medical Products Administration (NMPA) on October 30, 2017, addresses a labeling inconsistency. The primary issue identified was that products from batch number AG2B2N, manufactured in February 2017, were labeled with an outdated registration certificate number. Although the product's approval was renewed on January 13, 2017, under the new certificate number 国械注进20173450240, some units inadvertently displayed the previous number. The company explicitly stated that this discrepancy does not impact product quality or patient safety. To rectify this, Asahi Kasei Medical Systems Co., Ltd. has directed distributors to immediately cease sales of the affected products and return all inventory. Distributors are also required to provide sales information for the recalled units. Furthermore, the company confirmed that previously sold or used products present no safety concerns. All returned recalled products are slated for destruction, ensuring compliance with regulatory labeling standards.