China NMPA Product Recall - Extracorporeal circulation arterial filter

On August 29, 2019, Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall for its Extracorporeal Circulation Arterial Filter, identified under Registration Certificate No. 20173456131. This action was overseen by the National Medical Products Administration (NMPA) and announced by the Shanghai Food and Drug Administration as Medical Device Recall 2019-214. The primary concern leading to the recall was the discovery that the sterile packaging of the arterial filters might be compromised during transportation. This potential damage could expose the product to non-sterile environments, leading to contamination. If a contaminated filter were to be used in an extracorporeal circulation main circuit, patients would be at risk of developing infections and infectious inflammatory syndrome, potentially causing a significant decline in their clinical condition. To address these serious patient safety risks, Maikewei (Shanghai) Medical Equipment Co., Ltd. voluntarily implemented the recall. Further specific details concerning the affected product models, specifications, and batch numbers are documented in the associated "Medical Device Recall Event Report Form."