# China NMPA Product Recall - Dilator, percutaneous nephrostomy catheter kit, percutaneous nephrostomy catheter, guidewire, guidewire, urethral dilation balloon catheter, ureteral stent tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-china-medical-trading-co-ltd/9a2f08c0-6926-417e-9dca-3a6c9468580a/
Source feed: China

> China NMPA product recall for Dilator, percutaneous nephrostomy catheter kit, percutaneous nephrostomy catheter, guidewire, guidewire, urethral dilation balloon catheter, ureteral stent tube by Cook (China) Medical Trading Co., Ltd. published January 04, 2019. Recall level: Level 2 Recall. Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II medical device recall on Janua

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook (China) Medical Trading Co., Ltd. is voluntarily recalling its products including dilators, percutaneous nephrostomy catheter kits, percutaneous nephrostomy catheters, guidewires, urethral dilation balloon catheters, and ureteral stents.
- Company Name: Cook (China) Medical Trading Co., Ltd.
- Publication Date: 2019-01-04
- Product Name: Dilator, percutaneous nephrostomy catheter kit, percutaneous nephrostomy catheter, guidewire, guidewire, urethral dilation balloon catheter, ureteral stent tube
- Recall Level: Level 2 Recall
- Recall Reason: Due to potential operational errors during the production process of loading the product into the guidewire protection tube, problems may arise such as the rigid end of the guidewire, rather than the flexible end, being guided into the human body.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook (China) Medical Trading Co., Ltd.
- Summary: Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II medical device recall on January 4, 2019, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall was prompted by identified operational errors during the production of guidewire protection tubes. This manufacturing issue could lead to a critical safety concern where the rigid tip of a guidewire might be inadvertently guided into a patient's body instead of the intended flexible tip. The affected products include dilators, percutaneous nephrostomy catheter kits, percutaneous nephrostomy catheters, guidewires, urethral dilatation balloon catheters, and ureteral stents. Cook (China) Medical Trading Co., Ltd. is responsible for implementing this recall, and detailed information regarding specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form" provided by the company.

Company: https://www.globalkeysolutions.net/companies/cook-china-medical-trading-co-ltd/1ed3054b-44a7-4626-85e1-6402cb7ef9e0/