China NMPA Product Recall - Radiofrequency tissue coagulation system

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall for its Radiofrequency Tissue Coagulation System (Model: GN200 RF Transmitter Main Unit). The recall, reported to the National Medical Products Administration (NMPA) in December 2016 and published in January 2017, stems from a defect in an electronic component supplied by a third party. This defect can lead to instrument malfunctions, indicated by error messages and audible alarms, potentially prolonging surgical procedures. While no patient injuries have been reported, the company proactively addressed the risk. The recall affects 72 imported units, with 70 having been sold in China, impacting specific serial numbers globally. As part of the corrective action, B. Braun Medical requires customers to verify and freeze all affected inventory, distribute recall notices, provide replacement instruments, and ensure all recalled products are returned to the manufacturer for proper management.