# China NMPA Product Recall - Medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/henan-huayu-medical-equipment-co-ltd/8c06d8fb-130d-4d4f-b79e-b6347ee5d674/
Source feed: China

> China NMPA product recall for Medical surgical masks by Henan Huayu Medical Equipment Co., Ltd. published August 28, 2020. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on August 28, 2020, that Henan Huayu M

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Henan Huayu Medical Equipment Co., Ltd. voluntarily recalls medical surgical masks.
- Company Name: Henan Huayu Medical Equipment Co., Ltd.
- Publication Date: 2020-08-28
- Product Name: Medical surgical masks
- Recall Level: Level 3 Recall
- Recall Reason: The mask strap breaking strength and other parameters did not meet the requirements.
- Discovering Company: Henan Huayu Medical Equipment Co., Ltd.
- Manufacturing Company: Henan Huayu Medical Equipment Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on August 28, 2020, that Henan Huayu Medical Device Co., Ltd. initiated a voluntary Level III recall for two batches of its medical surgical masks. This action followed the identification of multiple non-compliance issues with the products, as reported by the company on August 26, 2020.The first recalled batch, identified as Flat Type 200102, failed to meet regulatory standards due to substandard filtration efficiency and issues with the tensile strength of the mask straps. Following the detection of these deficiencies, the company promptly issued recall letters to user units. Investigations confirmed that this entire batch had been consumed, with no reported adverse reactions or events during clinical use, resulting in a recall quantity of zero units from users.A second recall involved medical surgical masks from production batch number 200206 (Flat Type, Large Size). These masks failed both bacterial filtration efficiency (BFE) and tensile strength tests. Henan Huayu Medical Device Co., Ltd. conducted an immediate inspection, determining that all units from this batch had already been sold, primarily to Beijing Yinuo Chuxin Jia'an Pharmaceutical Co., Ltd. Subsequently, the company issued a recall notice to the distributor, which also confirmed that their stock had been fully utilized.Operating under the NMPA's regulatory framework, both recalls were classified as Level III, indicating a situation where the use of the product is unlikely to cause adverse health consequences. The company's immediate issuance of recall notices and investigation into product usage demonstrated adherence to recall protocols.

Company: https://www.globalkeysolutions.net/companies/henan-huayu-medical-equipment-co-ltd/6adce2e5-53d9-417b-acc6-b7c5d190ba54/