China NMPA Product Recall - Medical surgical masks

Guangzhou Panyu District Haozheng Sanitary Materials Factory has initiated a voluntary Level 3 recall for its Medical Surgical Masks, identified under Registration Certificate No. 綵械注准20172641570. This action was reported to the National Medical Products Administration (NMPA) on August 29, 2019, affecting products from production batch 20190103. The primary issue involves a failure to meet technical requirements for gas exchange; specifically, four masks from the affected batch exhibited a pressure difference (Δp) exceeding the permissible 49Pa limit. This non-conformity suggests potential breathability issues, impacting the mask's intended protective function for both patients and medical personnel during invasive procedures. Approximately 30,000 units of the 17cm×17cm mask model were produced, with 29,850 units sold in China. To address this, the company has mandated immediate cessation of use for the affected batch, a comprehensive recall of all compromised products, and the systematic scrapping of the returned medical devices. This measure aims to mitigate potential adverse events and ensure compliance with medical device standards under NMPA oversight.