# China NMPA Product Recall - Disposable suction catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/suzhou-huahao-medical-equipment-co-ltd/5021ae48-178d-42a3-831f-c6e624fe77d5/
Source feed: China

> China NMPA product recall for Disposable suction catheter by Suzhou Huahao Medical Equipment Co., Ltd. published December 31, 2019. Recall level: Level 3 Recall. Suzhou Huahao Medical Device Co., Ltd. has initiated a voluntary Class III recall of its disposable 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Suzhou Huahao Medical Device Co., Ltd. has initiated a voluntary recall of disposable suction catheters.
- Company Name: Suzhou Huahao Medical Equipment Co., Ltd.
- Publication Date: 2019-12-31
- Product Name: Disposable suction catheter
- Recall Level: Level 3 Recall
- Recall Reason: The vacuum residual amount of the suction catheter vacuum control device is substandard.
- Discovering Company: Suzhou Huahao Medical Equipment Co., Ltd.
- Manufacturing Company: Suzhou Huahao Medical Equipment Co., Ltd.
- Summary: Suzhou Huahao Medical Device Co., Ltd. has initiated a voluntary Class III recall of its disposable suction catheters. This action follows a 2019 national medical device spot check, which identified a critical issue with the product. The main violation concerned the substandard vacuum residue found in the vacuum control device of the suction catheters, indicating a potential compromise in the device's intended performance and safety.

The recall is being conducted under the regulatory oversight of the National Medical Products Administration (NMPA) of China. A Class III recall typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences, but the company is taking corrective action to address the identified non-conformity. Specific models, specifications, and batch information for the affected disposable suction catheters (Registration Certificate Code: Su Xie Zhu Zhun 20172660824) are detailed in the company's "Medical Device Recall Event Report." This voluntary recall demonstrates the company's commitment to product quality and patient safety, aligning with NMPA's standards for medical device integrity.

Company: https://www.globalkeysolutions.net/companies/suzhou-huahao-medical-equipment-co-ltd/8d770d73-c417-4b76-9704-d430e8c0f730/