China NMPA Product Recall - Disposable fallopian tube catheters and accessories

On September 22, 2021, Shanghai Shangyi Kangge Medical Equipment Co., Ltd. initiated a voluntary Class III recall of its disposable fallopian tube catheters and accessories. This action, reported via the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, was prompted by the discovery of incorrect labeling information on specific product batches. The affected devices, registered under certificate number "沪械注准20172770755", are subject to this recall to ensure patient safety and compliance with regulatory standards. A Class III recall signifies that exposure to the recalled product is unlikely to cause adverse health consequences. While the document does not detail specific inspection dates, the company proactively reported this issue. Shanghai Shangyi Kangge Medical Equipment Co., Ltd. is responsible for implementing this recall, with comprehensive details regarding the specific models, specifications, and batch numbers of the affected products available in the accompanying Medical Device Recall Event Report Form. This recall underscores the importance of accurate product labeling within the medical device industry, as overseen by China's NMPA regulatory framework.