# China NMPA Product Recall - Guide wire Biwire Nitinol Core W

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/ddadf4ee-f1cd-41ce-88c7-1f531a1ea803/
Source feed: China

> China NMPA product recall for Guide wire Biwire Nitinol Core W by Cook Incorporated published August 23, 2024. Recall level: Level 3 Recall. Cook Incorporated, through Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated voluntarily recalls guidewires
- Company Name: Cook Incorporated
- Publication Date: 2024-08-23
- Product Name: Guide wire Biwire Nitinol Core W
- Recall Level: Level 3 Recall
- Recall Reason: EU MDD certificates for products sold in the UK have expired.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated, through Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class III recall of its Biwire Nitinol Core W guidewire. This action, announced by the National Medical Products Administration (NMPA) on August 23, 2024, stems from the expiration of the EU Medical Device Directive (MDD) certificate for products sold in the United Kingdom. The affected guidewires, registered under National Medical Device Registration Certificate No. 20162022175, were not imported into China. The primary issue driving this recall is the lapse in a critical regulatory certification required for market access in specific European regions. As a required action, the manufacturer is proactively removing these non-compliant products from distribution. This voluntary recall underscores the importance of maintaining up-to-date regulatory compliance across all sales territories. Comprehensive details regarding the specific models, specifications, and batches involved are fully documented in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/cook-incorporated/1824e76a-038e-4220-8016-501448925cf2/