China NMPA Product Recall - Right femoral artery electronic compression hemostat

The National Medical Products Administration (NMPA) announced a Level III voluntary recall initiated by Shenzhen Shengwu Technology Co., Ltd. for its Electronic Compression Hemostat for Right Femoral Artery. The recall, reported on November 1, 2018, was prompted by findings during a 2018 national medical device spot check. The primary issue identified was that product labels for specific batches, including KM171108, lacked the required classification mark for partial shock protection (Type B). This non-compliance violated sections 6.11 of GB9706.1-2007, titled 'Medical Electrical Equipment Part 1: General Safety Requirements,' and specific product technical requirements outlined in the Guangdong Medical Device Registration Certificate 20162540907 (section 2.1.7). The affected products, covering models 01-GF-A, 02-GF-A, and 03-GF-A, with various batch numbers, had 2581 units sold in China. Shenzhen Shengwu Technology Co., Ltd. was required to take several corrective actions. These included promptly notifying customers about the issue and providing necessary label classification markings. Furthermore, the company committed to rectifying its label printing molds to ensure future compliance. For all unsold inventory and products currently in production, temporary classification markings were to be applied until revised, qualified labels could be incorporated into the manufacturing process.