China NMPA Product Recall - Disposable medical masks

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.