# China NMPA Product Recall - Microcatheter Turnpike catheters

Source: https://www.globalkeysolutions.net/records/china_product_recall/vascular-solutions-llc-usa/52c93aa9-8113-44d9-a760-49b8774a76b9/
Source feed: China

> China NMPA product recall for Microcatheter Turnpike catheters by Vascular Solutions LLC (USA) published January 16, 2023. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued an announcement on January 16, 2023, conc

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Vascular Solutions LLC, a US-based cardiovascular interventional device company, is voluntarily recalling its Turnpike catheters.
- Company Name: Vascular Solutions LLC (USA)
- Publication Date: 2023-01-16
- Product Name: Microcatheter Turnpike catheters
- Recall Level: Level 3 Recall
- Recall Reason: The IPN for certain models and batches of products is not registered in the UK and does not have a CE mark.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Vascular Solutions LLC (USA)
- Summary: The National Medical Products Administration (NMPA) issued an announcement on January 16, 2023, concerning a voluntary Class III recall by Vascular Solutions LLC for specific models and batches of its Turnpike Catheters. The recall, reported by Tailifu Medical Devices Trading (Shanghai) Co., Ltd., addresses significant compliance issues. The affected products were found to be unregistered in the UK (lacking an IPN) and did not possess the mandatory CE marking, which is essential for market entry in Europe. Although the product holds an NMPA Registration Certificate (No.: 20213030098) in China, the recall highlights non-compliance with international regulatory standards. Vascular Solutions LLC initiated this voluntary action to rectify these regulatory discrepancies. Comprehensive details regarding the affected models, specifications, and batch numbers are documented in the "Medical Device Report Form".

Company: https://www.globalkeysolutions.net/companies/vascular-solutions-llc-usa/9fb2c443-62a6-41d7-bab6-5286eeab6fe6/