China NMPA Product Recall - Electric pneumatic hemostat

Zhejiang Longyou Lande Medical Technology Co., Ltd. initiated a voluntary recall of its Electric Pneumatic Hemostatic Device (Registration Certificate No.: Zhexiezhuzhun 20172540615), with the recall reported on January 17, 2019. This action was prompted by findings from a national medical device supervision and spot check conducted under the oversight of the National Medical Products Administration (NMPA).

The core issue identified was that the working status of the product's indicator charging device failed to meet the specified requirements outlined in GB9706.1-2007, indicating a non-compliance with the established product technical specifications. The specific affected product details include model LD-ATS-F, serial number ATSF1805001.

For corrective measures, the company is instructed to coordinate with the sampling agency, the Jiangsu Provincial Medical Device Inspection Institute, through the relevant municipal bureau to facilitate the return and confiscation of the product. Zhejiang Longyou Lande Medical Technology Co., Ltd. clarified that only a single unit of the device was produced for sampling inspection purposes, and no units were ever sold or distributed commercially. This event underscores the critical importance of adhering to national medical device standards and maintaining stringent quality controls.