China NMPA Product Recall - Disposable medical masks

On August 16, 2019, Nanchang Kaixuan Medical Device Co., Ltd. initiated a voluntary Class III recall for its disposable medical masks. This action was taken under the regulatory framework of the National Medical Products Administration (NMPA) due to a critical quality issue. The main violation identified was the failure of the breaking strength at the connection point between each mask strap and the mask body to meet the required standard. This deficiency could compromise the secure fit and overall efficacy of the masks.

As a required action, Nanchang Kaixuan Medical Device Co., Ltd. is recalling affected products to ensure compliance with quality benchmarks. The recall aims to address this non-conformance, with detailed information on specific models, specifications, and batches available in an accompanying "Medical Device Table" and a "Medical Device Recall Incident Report Form." This proactive measure by the company underscores its commitment to maintaining product safety and adhering to established medical device standards.