# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/zhejiang-yilubo-biotechnology-co-ltd/86ec4392-cee7-4236-8bda-5d553dfab703/
Source feed: China

> China NMPA product recall for Disposable medical masks by Zhejiang Yilubo Biotechnology Co., Ltd. published November 30, 2018. Recall level: Level 3. Zhejiang Yilubo Biotechnology Co., Ltd. initiated a Class III voluntary recall of its disposable med

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zhejiang Yilubo Biotechnology Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Zhejiang Yilubo Biotechnology Co., Ltd.
- Publication Date: 2018-11-30
- Product Name: Disposable medical masks
- Recall Level: Level 3
- Recall Reason: The product failed the bacterial filtration efficiency test in the national medical device quality supervision spot check, and it still failed the test after retesting.
- Discovering Company: Zhejiang Yilubo Biotechnology Co., Ltd.
- Manufacturing Company: Zhejiang Yilubo Biotechnology Co., Ltd.
- Summary: Zhejiang Yilubo Biotechnology Co., Ltd. initiated a Class III voluntary recall of its disposable medical masks (Registration Certificate No.: Zhexiezhuzhun 20162640370) following inspections and testing in 2018, with the National Medical Products Administration (NMPA) publishing the recall on November 30, 2018. The primary issue identified was the product's failure to meet national standards for bacterial filtration efficiency (BFE). Initial testing by the Henan Provincial Medical Device Testing Institute, and a subsequent re-test by the Beijing Medical Device Testing Institute, confirmed the non-compliance with standard requirements. The affected products comprised one batch, specifically 118 boxes (10 units/bag; 144 bags/box), identified by batch number 180402.

Under the NMPA's regulatory framework, the company is required to undertake several corrective actions. These include formally notifying all distributors to immediately cease sales of the non-compliant batch and recalling all 118 boxes currently on the market. Upon collection, all affected products are mandated for destruction under the supervision of the drug regulatory authority. Additionally, Zhejiang Yilubo Biotechnology Co., Ltd. committed to enhancing its warehouse management practices and investing in corresponding testing facilities to ensure future product compliance and prevent similar issues.

Company: https://www.globalkeysolutions.net/companies/zhejiang-yilubo-biotechnology-co-ltd/c6cca629-86b2-43fd-b2bc-19dc312f5a5f/