# China NMPA Product Recall - Medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangzhou-panyu-district-haozheng-sanitary-materials-factory/5636ae94-3766-4a49-b8a6-f671a05a4e60/
Source feed: China

> China NMPA product recall for Medical surgical masks by Guangzhou Panyu District Haozheng Sanitary Materials Factory published September 02, 2019. Recall level: Level 3 Recall. Guangzhou Panyu District Haozheng Sanitary Materials Factory has initiated a voluntary Level 3 recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangzhou Panyu District Haozheng Sanitary Materials Factory voluntarily recalls medical surgical masks.
- Company Name: Guangzhou Panyu District Haozheng Sanitary Materials Factory
- Publication Date: 2019-09-02
- Product Name: Medical surgical masks
- Recall Level: Level 3 Recall
- Recall Reason: The pressure difference Δp between the two sides of the mask for gas exchange should not exceed 49 Pa. Four masks exceeded 49 Pa, failing to meet the technical requirements. To prevent adverse events, our company has initiated a voluntary recall.
- Discovering Company: Guangzhou Panyu District Haozheng Sanitary Materials Factory
- Manufacturing Company: Guangzhou Panyu District Haozheng Sanitary Materials Factory
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/guangzhou-panyu-district-haozheng-sanitary-materials-factory/b9fb533c-297c-406e-9d0c-124f82c171d3/