# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/ningxia-qiyuan-pharmaceutical-co-ltd/5acb37b0-86b5-4931-be4a-c7e7865d4719/
Source feed: China

> China NMPA product recall for Disposable medical masks by Ningxia Qiyuan Pharmaceutical Co., Ltd. published November 26, 2020. Recall level: Level 3 Recall. Ningxia Quanshui Pharmaceutical Co., Ltd. initiated a voluntary Class III recall of approximately 53

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ningxia Quanshui Pharmaceutical Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Ningxia Qiyuan Pharmaceutical Co., Ltd.
- Publication Date: 2020-11-26
- Product Name: Disposable medical masks
- Recall Level: Level 3 Recall
- Recall Reason: The tensile strength of the mask straps does not meet the "Technical Requirements for Disposable Medical Masks," and some mask straps do not meet the 10N requirement.
- Discovering Company: Ningxia Quanshui Pharmaceutical Co., Ltd.
- Manufacturing Company: Ningxia Qiyuan Pharmaceutical Co., Ltd.
- Summary: Ningxia Quanshui Pharmaceutical Co., Ltd. initiated a voluntary Class III recall of approximately 53,952 units of its disposable medical masks (Batch Number: 20200411, specification: 175	atime95mm, flat, ear-loop type). This action followed findings from the 2020 Ningxia medical device sampling inspection risk monitoring, which revealed that the broken strength of some mask straps did not meet the required 10N standard. This non-compliance is a direct violation of the "Technical Requirements for Disposable Medical Masks," as outlined in the product's registration certificate (Ningxiezhuzhun 20202140002) issued under the regulatory framework of the National Medical Products Administration (NMPA). The company's required actions include immediately issuing a recall notice to distributors, instructing them to cease sales of the affected batch. Furthermore, Ningxia Quanshui Pharmaceutical Co., Ltd. will recall and uniformly replace all unused products from this batch currently held by distributors. For products that have already been used, follow-up visits will be conducted to address potential concerns. This recall aims to ensure product quality and compliance with established safety standards for medical devices.

Company: https://www.globalkeysolutions.net/companies/ningxia-qiyuan-pharmaceutical-co-ltd/c3f60fce-9615-4bb0-96fb-7df0b3242164/