# China NMPA Product Recall - Medical protective masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/hunan-yuankang-biotechnology-co-ltd/8fd408a1-1498-4b8e-b8a6-9eff551d4e31/
Source feed: China

> China NMPA product recall for Medical protective masks by Hunan Yuankang Biotechnology Co., Ltd. published July 13, 2020. Recall level: Level 3 Recall. Hunan Yuankang Biotechnology Co., Ltd. initiated a Class III voluntary recall of its medical protect

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hunan Yuankang Biotechnology Co., Ltd. voluntarily recalls medical protective masks
- Company Name: Hunan Yuankang Biotechnology Co., Ltd.
- Publication Date: 2020-07-13
- Product Name: Medical protective masks
- Recall Level: Level 3 Recall
- Recall Reason: The production of Class II medical devices that are inconsistent with the products listed in the Medical Device Production and Sales Product Registration Form is not the same as those produced.
- Discovering Company: Hunan Yuankang Biotechnology Co., Ltd.
- Manufacturing Company: Hunan Yuankang Biotechnology Co., Ltd.
- Summary: Hunan Yuankang Biotechnology Co., Ltd. initiated a Class III voluntary recall of its medical protective masks (batch number: PC20200324) on July 13, 2020. This action was prompted by the discovery that the company was producing and selling Class II medical devices that did not align with the product details registered in their official Medical Device Production Product Registration Form. The recall affects 5700 pieces distributed in regions including Beijing and Suzhou, China. Under the regulatory oversight of the National Medical Products Administration (NMPA) and adherence to its medical device registration standards (specifically 湘械注准202002140871), the company is required to undertake specific corrective measures. The primary violations involved deviations from the established product registration, indicating a non-compliance with the approved specifications for medical devices. As immediate required actions, Hunan Yuankang Biotechnology Co., Ltd. was instructed to promptly implement the Level III recall to remove the non-conforming products from the market. Furthermore, the company must cease all production and sales activities for medical protective masks that do not comply with their official product registration. This recall ensures that medical devices meet the stringent quality and safety standards mandated by regulatory authorities, protecting healthcare personnel and related staff from inappropriate product usage.

Company: https://www.globalkeysolutions.net/companies/hunan-yuankang-biotechnology-co-ltd/c49ced85-fb4d-4ca3-a26e-639202ad9b20/