China NMPA Product Recall - medical masks

Hebi Liyangli Medical Device Co., Ltd. initiated a voluntary Level III recall of certain medical masks, as formally reported to the National Medical Products Administration (NMPA) and the Henan Provincial Drug Administration on November 18, 2020. This action followed a provincial bureau's inspection which identified that some mask straps failed to comply with established standards. The specific issue was the non-compliance of mask straps with regulatory requirements. The recall involved products from production batch 20200710, totaling 96,000 pieces, with 48,000 having been sold in China, primarily in Guangzhou City, Guangdong Province. In response, Hebi Liyangli promptly organized an investigation involving management, production, business, and quality departments, conducting extensive testing on retained samples and existing stock. The company’s required actions included notifying all purchasing units to ensure a complete recall of the affected products. Recalled items underwent further sampling and testing; those that met quality standards were repackaged, while non-compliant products were incinerated and subsequently buried for proper disposal, ensuring adherence to medical device regulations.