# China NMPA Product Recall - Vascular sheathFlexor Check-Flo Introducer Sets

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/ec64bfcc-939c-467a-b701-a167179d51df/
Source feed: China

> China NMPA product recall for Vascular sheathFlexor Check-Flo Introducer Sets by Cook Incorporated published October 27, 2021. 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 is voluntarily recalling its Flexor Check-Flo Introducer Sets.
- Company Name: Cook Incorporated
- Publication Date: 2021-10-27
- Product Name: Vascular sheathFlexor Check-Flo Introducer Sets
- Recall Level: Level 2 Recall
- Recall Reason: Problem of incorrect position of nontransparent line marking
- 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 Flexor Check-Flo Introducer Sets. This recall, announced on October 27, 2021, by the National Medical Products Administration (NMPA), addresses a critical issue involving incorrect radiopaque markings on specific models and batches of the product (Registration Certificate No.: 20173031481). The presence of inaccurate radiopaque markings could potentially lead to misinterpretation during medical procedures, posing risks to patient safety and the effectiveness of the device's intended use. The voluntary nature of this recall indicates Cook Incorporated's proactive approach to ensuring product quality and patient safety in adherence to regulatory standards. While specific inspection dates are not provided in the document, the NMPA's involvement highlights the regulatory oversight framework governing medical devices in China. The required action for the company is to identify and remove the affected Flexor Check-Flo Introducer Sets from the market. A Class II recall signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. This emphasizes the importance of promptly addressing the identified defect to mitigate potential patient harm. Detailed information on the specific product models, specifications, and batch numbers subject to the recall is contained within the "Medical Device Recall Event Report Form" attachment, which stakeholders can consult for comprehensive details.

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