China NMPA Product Recall - Electric pneumatic hemostat

Hangzhou Zhengda Medical Device Co., Ltd. initiated a voluntary product recall for its Electric Pneumatic Hemostat (model YTQ-E, product number ATSE1802022), as announced by the National Medical Products Administration (NMPA) on January 17, 2019. This action followed a national medical device supervision and spot check that identified several critical issues. The primary violations included a labeling error where the displayed input power did not meet regulatory standards. Furthermore, the device's charging status indication failed to comply with the GB9706.1-2007 standard, and the product did not meet its own specified technical requirements. These non-conformities underscore a breach of the regulatory framework governing medical devices in China. In response, the company undertook a voluntary recall for the single affected unit. Required actions involved immediate contact with the sampling agency, the Shanghai Medical Device Inspection Institute, and liaison with the relevant Municipal Bureau. This recall highlights the NMPA's commitment to ensuring product safety and adherence to established quality and labeling standards within the medical device industry.