China NMPA Product Recall - Mechanical release spring coil system

Jiaqi Biotechnology (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its mechanical release coil system, a medical device, on December 18, 2019. The company discovered that a removable silicone plug, which secures the device's handle gap, could detach and fall into the product's packaging under external force. While Jiaqi Biotechnology clarified that this issue does not pose a direct risk to human health, the recall was deemed necessary to maintain product quality assurance standards. This action was taken within the regulatory framework overseen by the National Medical Products Administration (NMPA), under whose registration certificate the product operates, and reported to the Shanghai Municipal Drug Administration. The company's required action involves retrieving affected products from the market, with comprehensive details regarding specific models, specifications, and batch numbers provided in an accompanying Medical Device Recall Event Report Form. This demonstrates the company's commitment to stringent quality control and compliance with NMPA guidelines.