# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/henan-huayu-medical-equipment-co-ltd/2996e824-d1f2-4035-9ccd-e8b237c34fe8
Source feed: China

> China NMPA product recall for Disposable medical masks by Henan Huayu Medical Equipment Co., Ltd. published December 16, 2019. Recall level: Level 3. Henan Huayu Medical Device Co., Ltd. initiated a voluntary Level III recall of its disposable medica

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Henan Huayu Medical Equipment Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Henan Huayu Medical Equipment Co., Ltd.
- Publication Date: 2019-12-16
- Product Name: Disposable medical masks
- Recall Level: Level 3
- Recall Reason: The disposable medical masks failed the bacterial filtration efficiency (BFE) and sterility tests.
- Discovering Company: Henan Huayu Medical Equipment Co., Ltd.
- Manufacturing Company: Henan Huayu Medical Equipment Co., Ltd.
- Summary: Henan Huayu Medical Device Co., Ltd. initiated a voluntary Level III recall of its disposable medical masks, as announced by the National Medical Products Administration (NMPA) on December 16, 2019. The recall was prompted by significant quality concerns, specifically substandard bacterial filtration efficiency (BFE) and sterility, which are critical for the product's intended use in preventing the transmission of pathogens. The affected product, a flat-model disposable medical mask from production batch number 20180906, had 3000 units produced. The company reported that the entire batch had already been sold, with 1000 units supplied to Binzhou City Zhanhua District People's Hospital. Upon discovering the non-conformities, Henan Huayu Medical Device Co., Ltd. immediately inspected its finished goods inventory and issued recall notices to the affected sales and user units. However, investigations revealed that the specific batch sold to Zhanhua District People's Hospital had already been fully utilized by the time the recall was initiated, meaning no physical products were retrieved from that site. The company's actions aimed to address the non-compliant product under the NMPA's regulatory framework, though the immediate impact on product recovery was limited due to prior consumption.

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