China NMPA Product Recall - Right femoral artery electronic compression hemostat

The National Medical Products Administration (NMPA) announced a voluntary Level 3 recall initiated by Shenzhen Shengwu Technology Co., Ltd. on November 1, 2018, concerning its Electronic Compression Hemostat for the Right Femoral Artery. This action followed a 2018 national medical device spot check, which found that certain product batches, including KM171108, did not meet regulatory labeling standards.The core issue was the absence of the "partial shock protection symbol Type B" classification mark on product labels. This deficiency violated GB9706.1-2007, Medical Electrical Equipment Part 1: General Safety Requirements (6.11), and the product's specific technical requirements as per Guangdong Medical Device Registration Certificate 20162540907 (2.1.7). The recall affects 2581 units across models 01-GF-A, 02-GF-A, and 03-GF-A, sold in China.As corrective measures, Shenzhen Shengwu Technology Co., Ltd. is notifying customers and providing supplementary classification markings. The company is also rectifying its label printing molds for future production and is applying temporary classification markings to all unsold inventory and products in production until fully compliant labels are manufactured and implemented. This ensures all devices adhere to required safety and labeling specifications.