China NMPA Product Recall - Medical surgical masks

Nanchang Donghai Medical Equipment Co., Ltd. initiated a voluntary Level 3 recall of its Medical Surgical Masks (batch number 20201126) following a random inspection by the Jiangxi Provincial Medical Device Testing Center on July 28, 2021. The inspection, conducted at Qianshan County Central Hospital, revealed a quality issue where the mask straps were substandard due to poor pressure. This recall affects 40,000 units of flat earloop, medium-sized masks sold in Nanchang, Jiangxi Province, China. The regulatory framework for this action falls under the National Medical Products Administration (NMPA) and provincial authorities. Required actions include stopping the use of all affected products, issuing a recall notice, reviewing the substandard items, and implementing proper handling methods. The company also committed to making improvements, including corrective and preventative measures, before resuming sales of the modified products.