# China NMPA Product Recall - Disposable masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiangxi-aiyi-sanitary-materials-co-ltd/e7fd8081-d596-41cd-85dd-dd3f320b1044/
Source feed: China

> China NMPA product recall for Disposable masks by Jiangxi Aiyi Sanitary Materials Co., Ltd. published June 22, 2020. Recall level: Level 3 Recall. Jiangxi Aiyi Sanitary Materials Co., Ltd. initiated a voluntary Class III recall of its disposable m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiangxi Aiyi Sanitary Materials Co., Ltd. voluntarily recalls disposable masks.
- Company Name: Jiangxi Aiyi Sanitary Materials Co., Ltd.
- Publication Date: 2020-06-22
- Product Name: Disposable masks
- Recall Level: Level 3 Recall
- Recall Reason: Ventilation resistance does not meet standard requirements
- Discovering Company: Jiangxi Aiyi Sanitary Materials Co., Ltd.
- Manufacturing Company: Jiangxi Aiyi Sanitary Materials Co., Ltd.
- Summary: Jiangxi Aiyi Sanitary Materials Co., Ltd. initiated a voluntary Class III recall of its disposable masks (Registration Certificate No. 20152640189), as publicly reported on June 22, 2020. This action was taken due to the products' non-compliance with established ventilation resistance standards, a critical quality parameter for medical devices designed to ensure user safety and efficacy.
The regulatory oversight for this recall falls under the purview of the National Medical Products Administration (NMPA) and the Jiangxi Provincial Drug Administration in China. The company's proactive measure to recall the affected masks underscores its responsibility to adhere to stringent medical device regulations.
As part of the required actions, Jiangxi Aiyi Sanitary Materials Co., Ltd. has submitted a "Medical Device Recall Event Report Form," which contains specific details concerning the models, specifications, and batch numbers of the impacted products. This document facilitates the comprehensive identification and retrieval of non-compliant items from the market, safeguarding public health. The company's voluntary recall demonstrates an immediate response to quality control issues under the existing regulatory framework.

Company: https://www.globalkeysolutions.net/companies/jiangxi-aiyi-sanitary-materials-co-ltd/516330d5-3056-43f8-935d-13dd27879b30/