China NMPA Product Recall - Radiofrequency tissue coagulation system

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its Radiofrequency Tissue Coagulation System (Registration No.: CFDA Imported Medical Device No. 20143252954). This action, reported on June 19, 2017, by the company to the Provincial Food and Drug Administration, supplements an original recall report from December 14, 2016. The recall stems from a defect in electronic components supplied by a third party, affecting specific units of the GN200 RF Transmitter Main Unit. These defective components could lead to instrument malfunctions under certain circumstances, although the system is designed to self-detect the issue, displaying error messages and emitting an audible alarm. The product is intended for tissue hemostasis and vascular coagulation in surgical procedures. While no patient injuries have been reported, the company recognized a potential risk of prolonged surgery time. Under the regulatory framework of the National Medical Products Administration (NMPA), the company is required to verify and freeze all affected product inventory in China, send recall notices to customers to obtain receipts, and ensure all recalled products are returned to the manufacturer. This systematic approach aims to effectively remove the potentially compromised devices from circulation.