# China NMPA Product Recall - Right femoral artery electronic compression hemostat

Source: https://www.keypedia.com/records/china_product_recall/shenzhen-jingsheng-technology-co-ltd/618bac0a-e785-4d01-9c8e-580779ce0934
Source feed: China

> China NMPA product recall for Right femoral artery electronic compression hemostat by Shenzhen Jingsheng Technology Co., Ltd published November 06, 2018. Recall level: Level 3. The National Medical Products Administration (NMPA) announced a voluntary Level 3 recall initiated b

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Shenghao Technology Co., Ltd. is voluntarily recalling its right femoral artery electronic compression hemostat.
- Company Name: Shenzhen Jingsheng Technology Co., Ltd
- Publication Date: 2018-11-06
- Product Name: Right femoral artery electronic compression hemostat
- Recall Level: Level 3
- Recall Reason: During the 2018 national medical device spot check, it was found that the product label with production batch number KM171108 did not have a classification mark: the application of the partial electric shock protection level symbol type B mark, which does not comply with the classification requirements of 6.11 in "GB9706.1-2007 Medical Electrical Equipment Part 1: General Safety Requirements" and the product technical requirements (Guangdong Medical Device Registration Certificate 20162540907) 2.1.7.
- Discovering Company: Shenzhen Shenghao Technology Co., Ltd.
- Manufacturing Company: Shenzhen Jingsheng Technology Co., Ltd
- Summary: 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.

Company: https://www.keypedia.com/companies/shenzhen-jingsheng-technology-co-ltd/5f5a209d-96e3-4dde-8693-2b174c168841