# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/zhejiang-yilubo-biotechnology-co-ltd/f594fdba-04c7-4929-af5d-216bf8f7d894
Source feed: China

> China NMPA product recall for Disposable medical masks by Zhejiang Yilubo Biotechnology Co., Ltd. published December 03, 2018. Recall level: Level 3. Zhejiang Yilubo Biotechnology Co., Ltd. initiated a Class III voluntary recall for its disposable me

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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: 2018-12-03
- Product Name: Disposable medical masks
- Recall Level: Level 3
- Recall Reason: The product's bacterial filtration efficiency is substandard.
- 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 for its disposable medical masks (Registration Certificate No.: Zhexiezhuzhun 20162640370). The recall, reported on November 5, 2018, and publicized by the National Medical Products Administration (NMPA) on December 3, 2018, was prompted by the product's failure to meet national quality standards. Specifically, independent testing commissioned by the State Drug Administration, conducted by the Henan Provincial Medical Device Testing Institute and re-tested by the Beijing Medical Device Testing Institute, confirmed that the bacterial filtration efficiency, particularly the fine band filtration efficiency, of batch 180402 did not comply with regulatory requirements. The affected product, identified as flat/176mm*97mm masks, involved 118 boxes distributed in China. In response, the company took several actions: formally notifying all distributors to cease sales of the non-compliant batch, recalling all existing products from the market, and committing to the complete destruction of the recalled batch under regulatory supervision. Furthermore, the company plans to strengthen warehouse management and enhance internal testing facilities to prevent recurrence and ensure future compliance.

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