# China NMPA Product Recall - GORE PROPATEN Vascular Graft

Source: https://www.globalkeysolutions.net/records/china_product_recall/wl-gore-associates-inc/5b32c76d-1774-4d38-9fcd-8135a9ac84c6/
Source feed: China

> China NMPA product recall for GORE PROPATEN Vascular Graft by W.L. Gore & Associates, Inc. published January 11, 2024. Recall level: Level 3 Recall. On January 11, 2024, the National Medical Products Administration (NMPA) announced a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: W. L. Gore & Associates, Inc. has initiated a voluntary recall of artificial blood vessels.
- Company Name: W.L. Gore & Associates, Inc.
- Publication Date: 2024-01-11
- Product Name: GORE PROPATEN Vascular Graft
- Recall Level: Level 3 Recall
- Recall Reason: The actual length of the affected product differs from the length shown on the label.
- Discovering Company: Gore Industrial Products Trading (Shanghai) Co., Ltd.
- Manufacturing Company: W.L. Gore & Associates, Inc.
- Summary: On January 11, 2024, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by W. L. Gore & Associates, Inc., reported by its local entity, Gore Industrial Products Trading (Shanghai) Co., Ltd. The recall pertains to the GORE PROPATEN Vascular Graft, which holds National Medical Device Registration Certificate 20153133918. The primary issue identified was a critical discrepancy between the actual length of specific affected products and the length stated on their respective labels. This labelling error could potentially lead to incorrect device selection or usage, posing a risk to patient safety. As a corrective measure under the NMPA's regulatory oversight, W. L. Gore & Associates, Inc. is voluntarily recalling the affected batches of these artificial blood vessels. Further comprehensive details regarding the specific models, specifications, and batch numbers involved are available in the official "Medical Device Recall List" and the "Medical Device Recall Event Report Form" attachments, which provide detailed information about the recall event and required actions for distributors and healthcare providers. This action underscores the manufacturer's commitment to product quality and patient safety in compliance with medical device regulations.

Company: https://www.globalkeysolutions.net/companies/wl-gore-associates-inc/69dc2148-4a5b-45c0-833a-70a06acdbc97/