China NMPA Product Recall - Radiofrequency cutting coagulation device

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its radiofrequency cutting and coagulation devices, as announced by the National Medical Products Administration (NMPA) on December 20, 2019. This decisive action was prompted by critical post-marketing surveillance feedback received by the manufacturer, Aesculap AG. It was discovered that a key component, specifically the fixing plug at the jaw of the disposable cutting and hemostatic device, model PL730SU, was prone to loosening and detaching. This defect rendered the medical device inoperable during use, raising significant concerns about patient safety and the device's intended efficacy.

The company undertook this recall to proactively address the potential risks associated with the device's malfunction. The affected products include those registered under certificate number 国食药监械（进）字2014第3254779号. Under the regulatory oversight of the NMPA and reported through the Shanghai Municipal Drug Administration, B. Braun Medical (Shanghai) was required to publish a comprehensive "Medical Device Recall Event Report Form." This essential document details the specific product models, specifications, and batch numbers involved in the recall, ensuring transparent communication and facilitating the proper removal of defective units from circulation. This action demonstrates the company's commitment to product safety and adherence to medical device regulations in China.