China NMPA Product Recall - Disposable masks

The National Medical Products Administration (NMPA) announced on August 30, 2019, a voluntary Class III recall initiated by Jiangxi Hengbang Medical Device Co., Ltd. This action pertains to specific batches of their disposable masks, identified under Registration Certificate No. Ganxiezhuzhun 20162640114. The primary issue prompting this recall was the failure of the tensile strength at the connection point between each mask strap and the mask body to meet required standard specifications. This deficiency could compromise the secure fit and overall effectiveness of the masks. Under the regulatory framework of the NMPA, Jiangxi Hengbang Medical Device Co., Ltd. is required to implement recall procedures to remove the non-conforming products from the market. Detailed information regarding the models, specifications, and batch numbers of the affected products is provided in the accompanying 'Medical Device Recall Event Report Form.' This proactive measure aims to ensure product quality and uphold public health and safety standards.