# China NMPA Product Recall - Disposable central venous catheter kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/9586cd16-9fd8-4254-b6ad-7bfa6fe528ed/
Source feed: China

> China NMPA product recall for Disposable central venous catheter kit by Cook Incorporated published May 07, 2019. Recall level: Level 2 Recall. Cook Incorporated, through its agent Cook (China) Medical Trading Co., Ltd., initiated a Class II vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated is voluntarily recalling single-use central venous catheter kits.
- Company Name: Cook Incorporated
- Publication Date: 2019-05-07
- Product Name: Disposable central venous catheter kit
- Recall Level: Level 2 Recall
- Recall Reason: The product may have a defective aperture; the distal aperture of some catheters may not be able to pass through a 0.025-inch guidewire, which may cause a slight delay in surgery due to the need for catheter replacement.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated, through its agent Cook (China) Medical Trading Co., Ltd., initiated a Class II voluntary recall of specific single-use central venous catheter kits. This action was officially reported on April 26, 2019, and publicly announced by the National Medical Products Administration (NMPA) on May 7, 2019. The recall stems from a manufacturing defect discovered in some catheter batches, where a potential orifice defect prevents a 0.025-inch guidewire from passing through the distal diameter. This issue, while not presenting an immediate patient safety hazard, could potentially lead to minor surgical delays due to the need for catheter replacement. The affected products, registered under certificate No. 20173775089, are utilized for various medical procedures including drug administration and central venous pressure measurement. The recall impacts several international regions, including the United States, Belgium, Italy, Spain, the United Kingdom, and India. The manufacturer is undertaking corrective measures to address the defect. Notably, the specific affected batches were not imported into China, thus negating the need for direct recall actions or handling methods within the country. This recall process adheres to the NMPA's regulatory framework for medical device safety, as detailed in the 'Medical Device Recall Report Form'.

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