China NMPA Product Recall - Medical surgical masks

The National Medical Products Administration (NMPA) announced on December 10, 2018, that Nanchang Eisai Medical Device Co., Ltd. initiated a voluntary recall of its medical surgical masks. The recall, classified as Level III, was prompted because the affected masks, identified by Registration No.: (准)字2014第2640200号, did not meet standard requirements for critical performance parameters, specifically pressure difference and gas exchange. These deficiencies indicate that the masks may not perform effectively as protective barriers in medical environments. Nanchang Eisai Medical Device Co., Ltd. undertook this action voluntarily under the regulatory framework of the NMPA, which oversees medical products in China. Further details concerning the specific models, specifications, and batch numbers of the impacted products are documented in a "Medical Device Recall Event Report Form." This recall highlights the ongoing efforts to maintain product quality and patient safety within the medical device sector.