China NMPA Product Recall - Medical masks (non-surgical)

The National Medical Products Administration (NMPA) announced on July 12, 2019, a voluntary product recall initiated by Jiangxi Gomei Medical Supplies Co., Ltd. This recall specifically affects the company's non-surgical medical masks (NMPA Medical Device Approval No. 20142640289). The fundamental issue prompting this action is a critical quality failure: the tensile strength at the connection between the mask strap and the mask body does not meet established standard requirements. This defect presents a risk to the mask's functionality, potentially leading to its failure during use and compromising the intended protective barrier. Under the NMPA's regulatory oversight, this product withdrawal has been classified as a Level III recall. This classification signifies that while the product is violative, its use or exposure is not expected to cause serious adverse health consequences. In response to this finding, Jiangxi Gomei Medical Supplies Co., Ltd. is undertaking a voluntary recall of all affected product batches. Comprehensive information, including the specific models, specifications, and batch details of the recalled items, is provided in the official "Medical Device Recall Event Report Form" attached to the NMPA's announcement.