China NMPA Product Recall - Disposable masks

Nanchang Yimin Medical and Sanitary Materials Co., Ltd. initiated a voluntary Level III recall of its disposable masks, as publicly announced by the National Medical Products Administration (NMPA) on August 8, 2019. This action was prompted by critical quality deficiencies identified in the product, specifically concerning the elasticity and breaking strength at the mask body's connection point, which failed to meet established standard requirements. These non-conformities could potentially compromise the mask's effectiveness and user safety. The affected product is identified by Registration Certificate No. Ganxiezhuzhun 20182640081.

Operating under the NMPA's regulatory framework, the company's decision to conduct a Level III recall indicates that while the issue is significant, the use of the product is unlikely to cause severe adverse health consequences. Nanchang Yimin Medical and Sanitary Materials Co., Ltd. is taking the required action to remove these non-compliant devices from the market. Further detailed information, including specific product models, specifications, and batch numbers involved in the recall, is available in the associated "Medical Device Recall Event Report Form," demonstrating the company's commitment to addressing the identified quality concerns proactively.