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

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-jingsheng-technology-co-ltd/25b03476-2d05-4ba8-a228-8d4afd7352ad/
Source feed: China

> China NMPA product recall for Right femoral artery electronic compression hemostat by Shenzhen Jingsheng Technology Co., Ltd published November 26, 2018. Recall level: Level 3. Shenzhen Shenghao Technology Co., Ltd. initiated a voluntary Class III recall of its Electronic Comp

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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: 2018-11-26
- 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: Shenzhen Shenghao Technology Co., Ltd. initiated a voluntary Class III recall of its Electronic Compression Hemostat for Right Femoral Artery. This action stemmed from a labeling deficiency identified during a 2018 national medical device spot check, with the recall formally reported on November 1, 2018, and published by the National Medical Products Administration (NMPA) on November 26, 2018. The primary issue was that product labels for several batches, including KM171108, lacked the required classification mark for partial shock protection (Type B symbol). This non-compliance violated established regulatory standards, specifically GB9706.1-2007 for Medical Electrical Equipment Safety (Section 6.11) and the product's technical requirements (Section 2.1.7 of Guangdong Medical Device Registration Certificate 20162540907). A total of 2581 affected units were sold in China. As corrective actions, Shenzhen Shenghao Technology Co., Ltd. committed to notifying customers and providing them with the necessary classification markings. Furthermore, the company will promptly rectify label printing molds for future production and temporarily affix correct classification markings to all unsold inventory and products currently in production until fully compliant labels are manufactured and implemented. These measures aim to ensure all devices meet essential safety labeling requirements.

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