# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/yuan-henan-holding-co-ltd/def1e5a4-acf9-49eb-930b-dc4b1104f5e3/
Source feed: China

> China NMPA product recall for Disposable medical masks by Yu"an (Henan) Holding Co., Ltd. published October 30, 2020. Recall level: Level 3. Yu'an (Henan) Holding Co., Ltd. has initiated a voluntary Level III recall of a specific batch of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Yu'an (Henan) Holding Co., Ltd. voluntarily recalls disposable medical masks.
- Company Name: Yu"an (Henan) Holding Co., Ltd.
- Publication Date: 2020-10-30
- Product Name: Disposable medical masks
- Recall Level: Level 3
- Recall Reason: The tensile strength at the connection point between the mask strap and the mask body does not meet the requirements.
- Discovering Company: Yu'an (Henan) Holding Co., Ltd.
- Manufacturing Company: Yu"an (Henan) Holding Co., Ltd.
- Summary: Yu'an (Henan) Holding Co., Ltd. has initiated a voluntary Level III recall of a specific batch of its disposable medical masks, as reported to the Henan Provincial Drug Administration on September 28, 2020. The recall, indexed by the National Medical Products Administration (NMPA), concerns disposable medical masks (Registration Certificate Code: "械注准20202140676") identified by Batch Number 20022221.
The primary issue prompting this recall is the non-compliance with required tensile strength standards. Specifically, the connection point between the mask strap and the mask body failed to meet established specifications, posing a potential quality concern for users. The affected production batch comprised 30,100 units, with 30,000 units having been sold, predominantly to Alashankou Jurentang Pharmaceutical Sales Co., Ltd.
Under the NMPA's regulatory framework for medical devices, Yu'an (Henan) Holding Co., Ltd. is taking corrective actions. These actions include notifying distributors of the recall, ensuring the affected products are removed from circulation. A Level III recall signifies that while the product is violative, its use is not likely to cause adverse health consequences. This action underscores the company's commitment to product quality and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/yuan-henan-holding-co-ltd/92c7f4ed-ba93-4e06-8ac7-a75bb13fb908/