China NMPA Product Recall - Medical protective masks D918 and D912

Shandong Sino Medical Device Co., Ltd. initiated a voluntary recall of its medical protective masks, models D918 and D912 (Registration Certificate No.: Lu Xie Zhu Zhun 20172140062), effective July 1, 2022. The company's decision stems from the discovery of material defects in components supplied by certain vendors, which became apparent after extended storage periods. This voluntary action, categorized as a Level III recall, aims to address the identified product issues and ensure public safety. The recall details, including specific models, specifications, and affected product batches, are further elaborated in an accompanying "Medical Device Recall Event Report Form." This recall is overseen within the regulatory framework of the National Medical Products Administration (NMPA), with the initial announcement published by the Shandong Provincial Drug Administration. Shandong Sino Medical Device Co., Ltd. is undertaking the necessary steps to manage and resolve the identified product non-conformance through this voluntary recall process.