China NMPA Product Recall - Blood purification circuit

Asahi Kasei Medical Devices (Hangzhou) Co., Ltd. initiated a voluntary Class 3 recall of its Blood Purification Circuits following a self-inspection that identified critical labeling inaccuracies. The primary issue involved an error in the Chinese label for the product, specifically an incorrect registration certificate number and product name. This discovery led the company to report the event to the provincial Food and Drug Administration, operating under the regulatory oversight of China's National Medical Products Administration (NMPA), formerly known as the CFDA. The affected product, identified by Registration Certificate No. CFDA (Imported) No. 20133453018, is designed for various blood purification therapies, including plasma exchange, leukocyte adsorption, and blood cell removal. It serves as a vital tubing system connecting patients to different blood processing components. The recall impacts models such as PE-CPSGNL1, with specific identification information like batch numbers 732140F and 733192F. A total of 84 sets of these affected products were sold within China. Asahi Kasei Medical Devices proactively reported this issue through a "Medical Device Recall Event Report Form" dated December 18, 2018. This action ensures compliance with national medical device regulations, addressing the labeling discrepancy to safeguard patient safety and maintain product integrity within the Chinese market.