China NMPA Product Recall - Disposable suction catheter

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.