China NMPA Product Recall - Disposable medical masks

Anhui Zhongjian Medical Device Co., Ltd. initiated a voluntary recall of a specific batch of its Disposable Medical Masks. This action, formally reported on August 29, 2021, and published by the National Medical Products Administration (NMPA) on August 30, 2021, addresses batch number 20210408, affecting 10,000 units distributed in the domestic market within Anhui Province. The main issue prompting this recall was a non-conformity identified with the product's packaging label. While the precise details of the labeling defect were not specified, it necessitated the company's immediate corrective measures.

The regulatory oversight for this event falls under the National Medical Products Administration and the Anhui Provincial Drug Administration. Anhui Zhongjian Medical Device Co., Ltd. had previously notified the Anhui Province authorities on August 25, 2021, detailing the necessary actions and handling procedures for the recalled masks. These masks are designated for use in medical institutions and home settings. This voluntary recall underscores the company's commitment to upholding product quality and safety standards, ensuring compliance with national medical device regulations, particularly regarding labeling accuracy for products supplied to consumers and healthcare providers. The specific recall level was not explicitly stated in the provided document.