# China NMPA Product Recall - Pleural cavity and pericardial drainage kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/4bd711d2-3c19-499e-82fe-d9847555acdb/
Source feed: China

> China NMPA product recall for Pleural cavity and pericardial drainage kit by Cook Incorporated published April 15, 2019. Recall level: Level 2. On April 15, 2019, the National Medical Products Administration (NMPA) publicized a Class II volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated is voluntarily recalling its pleural and pericardial drainage kits.
- Company Name: Cook Incorporated
- Publication Date: 2019-04-15
- Product Name: Pleural cavity and pericardial drainage kit
- Recall Level: Level 2
- Recall Reason: If the diameter of the catheter tip is smaller than the product standard value, the guidewire may not be able to be withdrawn, which may lead to surgical delays, additional surgeries, or organ/blood vessel damage.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: On April 15, 2019, the National Medical Products Administration (NMPA) publicized a Class II voluntary recall initiated by Cook Incorporated for specific batches of its pleural and pericardial drainage kits. Cook (China) Medical Trading Co., Ltd. reported the issue on April 8, 2019, concerning products with CFDA Registration Number 20133153888. The primary issue identified was a manufacturing defect where the catheter tip diameter in the affected kits was smaller than the standard value. This critical flaw could prevent the guidewire from being withdrawn after the drainage catheter's placement. Such a malfunction carries potential risks including delayed or prolonged medical procedures, the need for additional interventions, and possible organ or vascular damage during attempts to manipulate the catheter or remove the guidewire. Cook Incorporated voluntarily initiated the recall of these drainage catheter assemblies. Notably, the identified problematic batches were not imported into mainland China, meaning no direct actions or corrective measures were required within mainland China for these specific products. The recall primarily affected markets in Australia, Canada, France, Germany, India, Italy, South Korea, the United States, and Hong Kong, China, among others.

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