China NMPA Product Recall - Disposable puncture device

Jiangsu Celte Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its disposable puncture devices (Registration Certificate Code: Su Xie Zhu Zhun 20172222199). This action follows findings from the 2018 national medical device spot check, which identified non-compliance with established standards for the product's "fitting performance, sealing, and gas barrier properties." The recall was officially reported to the National Medical Products Administration (NMPA) and the relevant Provincial Food and Drug Administration Department on November 28, 2018, with public notification on November 29, 2018. The affected devices, specifically model 18052803, were produced in a batch size of 100 sets for distribution in China. As a required action, the company is recalling all units of the non-compliant product. According to the recall report, no stock of the affected batch remains unsold, indicating a complete recall effort. The company is responsible for ensuring all distributors are promptly informed and for the proper handling of the recalled medical devices to mitigate any potential risks associated with the identified performance issues. This measure underscores the company's commitment to regulatory compliance and patient safety under the NMPA's oversight.