# China NMPA Product Recall - Hydrophilic coated guidewire

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/16a414ea-626f-405a-9767-283c3ee71fa4/
Source feed: China

> China NMPA product recall for Hydrophilic coated guidewire by Cook Incorporated published December 07, 2016. Recall level: Level 1 Recall. Cook (China) Medical Trading Co., Ltd., representing Cook Medical Systems, Inc., upgraded the recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook (China) Medical Trading Co., Ltd. has changed the recall level of its hydrophilic coated guidewires to Level 1.
- Company Name: Cook Incorporated
- Publication Date: 2016-12-07
- Product Name: Hydrophilic coated guidewire
- Recall Level: Level 1 Recall
- Recall Reason: DSM Biomedical B.V. of the Netherlands is a raw material supplier for this product. Cook Medical of the United States has been notified that this raw material supplier has initiated a recall of DSM substrate P41002 and hydrophilic coating TC43003. The primary reason for the recall is the potential risk of glass fragment contamination (glass fragment size approximately 4-280µm). Due to this potential contamination by glass fragments, the following potential adverse events may occur: vascular injury, bleeding, and embolic particles in the circulatory system.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook (China) Medical Trading Co., Ltd., representing Cook Medical Systems, Inc., upgraded the recall level for its Hydrophilic Coated Guidewires to Level 1, as announced by China's National Medical Products Administration (NMPA) on December 7, 2016. The initial global voluntary recall (Level II) was launched due to a critical issue with raw materials supplied by DSM Biomedical B.V. The main violation centers on the potential for glass fragment contamination (ranging from 4 to 280 micrometers) in specific raw materials used in the guidewires. This contamination poses significant risks, including vascular injury, bleeding, and embolism, to patients undergoing peripheral vascular procedures. Cook (China) initially reported the recall to the Shanghai Food and Drug Administration on June 28, 2016. The upgrade to Level 1 in China followed a similar reclassification by the US FDA on September 6, 2016, emphasizing the serious nature of the potential hazards. Although no patient injuries or adverse events related to this issue had been reported by Cook Medical globally or in China at the time, the regulatory framework mandates immediate and comprehensive action. Required actions include Cook (China) notifying distributors within three days to return all unused affected products, who in turn must inform user institutions. All recalled medical devices will be destroyed by Cook (China), and appropriate compensation will be provided. For patients already treated with the product who show no related adverse events, no special intervention or follow-up is deemed necessary.

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