China NMPA Product Recall - Artificial blood vessels

The National Medical Products Administration (NMPA) published a notice on May 22, 2023, concerning a voluntary recall initiated by Gore & Associates. Specifically, Gore Industrial Products Trading (Shanghai) Co., Ltd. reported the recall of certain artificial blood vessels distributed in China. The primary issue identified, leading to this action, was the mislabeling of these medical devices. This recall affects artificial blood vessels registered under National Medical Device Registration Certificate No. 20173136984. The NMPA designated this as a Class III recall, which indicates that the use of, or exposure to, the affected product is unlikely to cause adverse health consequences. While specific models, specifications, and batch numbers are detailed in an attached 'Medical Device Recall Event Report Form,' the central regulatory concern is the need for accurate product information to ensure patient safety. Gore & Associates is proactively taking steps to address the mislabeling by voluntarily recalling the affected products, demonstrating adherence to NMPA regulatory standards and a commitment to product integrity within the medical device sector. The recall process aims to remove the mislabeled devices from circulation, thereby reducing any potential risks linked to incorrect product identification.