China NMPA Product Recall - ordinary medical masks

On January 22, 2020, the National Medical Products Administration (NMPA) issued a notice regarding a Level III voluntary recall initiated by Hunan Yongkang Medical Device Co., Ltd. on January 9, 2020. The recall pertained to ordinary medical masks, registered under 湘械注准20192140017, which failed to meet technical specifications, specifically the mask strap tensile strength. This issue affected 7,700 bags, each containing 10 masks from batch 20190903, sold in China.

In response, Hunan Yongkang Medical Device Co., Ltd. implemented several corrective actions. The company established a dedicated product recall team and tasked its sales department with informing medical device distributors and users about the product deficiency. A specialized warehouse was set up for the proper segregation and handling of the recalled products in accordance with Food and Drug Administration regulations. Furthermore, the company committed to investigating the underlying causes of the non-compliance and implementing necessary rectifications to ensure future product quality.