# China NMPA Product Recall - Disposable masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiangxi-zhonggan-medical-equipment-co-ltd/81352ad8-862c-4303-a2a7-917cfa879477/
Source feed: China

> China NMPA product recall for Disposable masks by Jiangxi Zhonggan Medical Equipment Co., Ltd. published September 05, 2019. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on September 5, 2019, details regardin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiangxi Zhonggan Medical Equipment Co., Ltd. voluntarily recalls disposable masks
- Company Name: Jiangxi Zhonggan Medical Equipment Co., Ltd.
- Publication Date: 2019-09-05
- Product Name: Disposable masks
- Recall Level: Level 3 Recall
- Recall Reason: Disposable masks failed sterility testing to meet standards.
- Discovering Company: Jiangxi Zhonggan Medical Equipment Co., Ltd.
- Manufacturing Company: Jiangxi Zhonggan Medical Equipment Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on September 5, 2019, details regarding a voluntary product recall initiated by Jiangxi Zhonggan Medical Device Co., Ltd. The recall involves disposable masks produced by the company due to significant non-compliance with established sterility testing standards. This issue suggests a potential compromise in the product's sterile integrity, which is critical for medical devices.Jiangxi Zhonggan Medical Device Co., Ltd. proactively commenced this recall, categorizing it as a Level III action. A Level III recall generally indicates that the use of, or exposure to, the affected product is unlikely to lead to serious adverse health consequences. Specific information detailing the models, specifications, and batch numbers of the disposable masks subject to recall is contained within the 'Medical Device Recall Event Report Form' referenced in the NMPA's official notice. As the primary regulatory body, the NMPA ensures adherence to safety and quality standards for medical products within its jurisdiction. While no specific inspection dates were provided in the document, the NMPA's publication of this voluntary recall underscores the company's commitment to address product quality issues and the regulatory framework's role in public health protection.

Company: https://www.globalkeysolutions.net/companies/jiangxi-zhonggan-medical-equipment-co-ltd/48644c3e-8f65-4dfd-9e2f-c437fe27c092/