China NMPA Product Recall - Angiographic Catheter

AngioDynamics Inc. initiated a voluntary Class II recall of its Angiographic Catheter due to an issue concerning incorrect product labeling. This recall was publicly reported by the National Medical Products Administration (NMPA) on December 6, 2024, through their index JGXX-2024-10218. The recall specifically addresses products manufactured by AngioDynamics Inc., which holds the National Medical Device Registration Number 20163032901 for the affected device. The regulatory framework governing this action is the NMPA, which oversees medical device safety and compliance. Shanghai Meichuang Medical Device Co., Ltd., as the local entity, was responsible for reporting this recall event. While the recall is in effect, it's important to note that the specific batches and models of Angiographic Catheters involved in this particular recall were confirmed not to have been imported into China. Detailed information regarding the precise model specifications and batch numbers is available in the "Medical Device Recall Event Report Form," an attached document associated with the NMPA's official announcement. This proactive measure by AngioDynamics Inc. underscores a commitment to product integrity and patient safety in adherence to regulatory standards, even for products not distributed within the Chinese market.