# China NMPA Product Recall - Support catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/844fc1af-1c77-4b9b-85fb-d389d6fb2784/
Source feed: China

> China NMPA product recall for Support catheter by Cook Incorporated published November 18, 2019. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) issued a voluntary recall notice (Index No. JGXX

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated's proactive recall of support catheters
- Company Name: Cook Incorporated
- Publication Date: 2019-11-18
- Product Name: Support catheter
- Recall Level: Level 2 Recall
- Recall Reason: This involves an error that occurred during the product manufacturing process.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: The National Medical Products Administration (NMPA) issued a voluntary recall notice (Index No. JGXX-2019-10769) on November 18, 2019, regarding a medical device manufactured by Cook Incorporated. The recall, reported by Cook (China) Medical Trading Co., Ltd., pertains to specific batches of a support catheter, identified by Registration Certificate No. 国械注进20163771336. The primary reason for this corrective action is an identified error in the manufacturing process. While no specific inspection dates are provided, the recall itself represents a regulatory response to the discovery of this quality issue, ensuring product safety. The regulatory framework governing this action is the NMPA in China, which oversees medical device quality and compliance. The recall has been designated as Class II, indicating a potential for temporary or medically reversible adverse health consequences, or a remote probability of serious health consequences. As a required action, Cook Incorporated is undertaking a voluntary recall of all implicated support catheters. Detailed information concerning the specific models, specifications, and batch numbers involved is available in the accompanying "Medical Device Recall Event Report Form," facilitating proper identification and management of affected products by healthcare providers and consumers. This action highlights the manufacturer's dedication to maintaining product safety standards and adhering to NMPA regulations.

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