# China NMPA Product Recall - Disposable masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanchang-medical-equipment-co-ltd/e6611ff9-f6af-4826-95f3-329f11aba4ea
Source feed: China

> China NMPA product recall for Disposable masks by Nanchang Medical Equipment Co., Ltd. published September 09, 2019. Recall level: Level 3 Recall. Nanchang Yuhua Medical Device Co., Ltd. has initiated a voluntary Class III recall for its disposabl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Yuhua Medical Device Co., Ltd. voluntarily recalls disposable masks
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2019-09-09
- Product Name: Disposable masks
- Recall Level: Level 3 Recall
- Recall Reason: The tensile strength test at the connection point between the ear loop mask and the mask body failed to meet the standard requirements.
- Discovering Company: Nanchang Yuhua Medical Equipment Co., Ltd.
- Manufacturing Company: Nanchang Medical Equipment Co., Ltd.
- Summary: Nanchang Yuhua Medical Device Co., Ltd. has initiated a voluntary Class III recall for its disposable ear-loop masks, specifically affecting products from batch number 20190402. The National Medical Products Administration (NMPA) issued this recall announcement on September 9, 2019. The core problem identified was that the ear-loop masks did not meet the required breaking strength standards at the connection point between the ear loop and the mask body. This defect raises concerns about the mask's structural integrity and its ability to maintain intended functionality during use. Under the regulatory guidance of the NMPA, the company is actively removing the impacted products, registered under Ganxiezhuzhun 20182640082, from the market. While a Class III recall generally indicates that the product is unlikely to cause serious adverse health consequences, it highlights a deviation from NMPA quality and safety regulations. Nanchang Yuhua Medical Device Co., Ltd. has provided the NMPA with a "Medical Event Report Form" detailing the specific models, specifications, and affected batches. This proactive measure demonstrates the company's dedication to upholding product quality and adhering to national medical device standards, ultimately safeguarding public health.

Company: https://www.globalkeysolutions.net/companies/nanchang-medical-equipment-co-ltd/7015714e-5b20-4940-b684-b1e40cb5f2ff
