China NMPA Product Recall - GORE PROPATEN Vascular Graft

W.L. Gore & Associates, Inc. initiated a voluntary Class III recall of its GORE PROPATEN Vascular Graft product, as reported by Gore Industrial Products Trading (Shanghai) Co., Ltd. on May 21, 2021. This action was taken in response to a labeling error discovered in specific models and batches of the vascular graft. The National Medical Products Administration (NMPA) of China oversees this recall, documented under Index No. JGXX-2021-10253. The affected product, registered under Certificate No. 20153133918, is subject to recall due to discrepancies in its labeling. A Class III recall indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. W.L. Gore & Associates, Inc. is proactively addressing this issue to ensure product integrity and compliance. Further detailed information regarding the specific models, specifications, and batch numbers impacted by this recall is available in the "Medical Device Recall Table" and the "Medical Device Recall Event Report Form" attachment provided by the NMPA. This voluntary recall highlights the company's commitment to product safety and adherence to regulatory standards.