China NMPA Product Recall - Type II vascular occlusion

On October 22, 2021, Abbott Medical Products (Shanghai) Co., Ltd. voluntarily initiated a Class II recall for its Type II vascular plugs. This significant regulatory action, publicized by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, was necessitated by identified inconsistencies between the packaging labels and the actual product information for a specific batch (7977776) of these critical medical devices. Six units of the affected model (9-AVP2-016) had been imported into China. The manufacturer, Abbott Medical Devices, is executing this recall. The core issue involves a discrepancy that could potentially impact product identification or usage, prompting the company to take corrective measures. The recall level, Class II, indicates a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This underscores the importance of adhering to stringent regulatory frameworks overseen by bodies like the NMPA, which ensure the safety and efficacy of medical products. Required actions involve the retrieval and management of the affected vascular plugs from the market. This proactive step by Abbott Medical Products (Shanghai) Co., Ltd. demonstrates compliance with established medical device regulations and a commitment to patient safety. Further specific details are provided within the accompanying "Medical Device Recall Event Report Form."