China NMPA Product Recall - Medical surgical masks

Henan Scorsese Technology Development Co., Ltd. initiated a voluntary Level III recall of its medical surgical masks due to a critical non-compliance issue identified during an inspection by the Henan Provincial Medical Device Supervision and Inspection. The primary violation concerned the product's bacterial filtration efficiency, which failed to meet the required technical standards. This deficiency, identified by the Henan Provincial Medical Device Testing Institute, indicated a potential compromise in the mask's ability to provide an effective physical barrier against pathogens, microorganisms, and particulate matter as intended for clinical medical personnel during invasive procedures. The recall, reported to the National Medical Products Administration (NMPA) and the Henan Provincial Drug Administration, involved a specific batch (Number 132002011) of flat-type, large-sized masks, with 7500 units originally sold in China. Although the company confirmed that all affected products had already been used, resulting in a recall quantity of zero, Henan Scorsese Technology Development Co., Ltd. is undertaking corrective actions. These actions include a comprehensive analysis to determine the root cause of the non-compliance and the formulation of preventive measures to ensure similar quality issues do not recur. The recall event report was dated April 6, 2020.