# China NMPA Product Recall - Drainage Catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/df051393-a73e-41da-8f92-0ff7541defbf/
Source feed: China

> China NMPA product recall for Drainage Catheter by Cook Incorporated published May 24, 2024. Recall level: Level 2 Recall. Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., has initiated a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated initiates voluntary recall of drainage catheters
- Company Name: Cook Incorporated
- Publication Date: 2024-05-24
- Product Name: Drainage Catheter
- Recall Level: Level 2 Recall
- Recall Reason: The product label indicates an incorrect expiration date.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class II recall of its Drainage Catheters. The recall, reported to the National Medical Products Administration (NMPA) of China, stems from a critical labeling error: an incorrect expiration date printed on the product labels. This issue affects medical devices registered under National Medical Device Registration Certificate No. 20192142121. This action falls under the regulatory oversight of the NMPA, which governs medical device safety and quality in China. A Class II recall indicates a situation where product use may cause temporary or medically reversible adverse health consequences, or where serious adverse health consequences are remote. As a required action, Cook Incorporated is retrieving all affected Drainage Catheters from the market. Specific details regarding the impacted product models, specifications, and batch numbers are documented in an accompanying "Medical Device Recall Event Report Form." This proactive measure by Cook aims to ensure patient safety and compliance with medical device labeling regulations.

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