China NMPA Product Recall - Hemostatic powder (trade name: Hexeting)

The National Medical Products Administration (NMPA) released an announcement on July 20, 2020, detailing a voluntary Class III recall initiated by Shanghai Chuanshen Medical Equipment Co., Ltd. The recall pertains to their hemostatic powder, marketed under the trade name Hexueting. The primary reason for this action was the discovery of incorrect shelf-life labeling on the product's Chinese label. While specific inspection dates were not provided in the document, the company proactively undertook this recall to address the labeling discrepancy and ensure regulatory compliance. The affected product, identified by Registration Certificate No. 国食药监械（进）字2014第3643670号, requires specific models, specifications, and batch numbers to be managed according to details in the Medical Device Recall Event Report Form. This event highlights the NMPA's framework for overseeing medical device quality and the manufacturer's responsibility to adhere to established labeling standards for patient safety.