China NMPA Product Recall - Disposable medical surgical masks

Shaoyang Qiankangyi Medical Device Co., Ltd. initiated a voluntary Level III recall of its disposable medical surgical masks (Registration Number: Xiangxiezhuzhun 20162640039) on September 6, 2017. This action was prompted by a critical product performance deviation identified during sampling. The masks failed to meet the specified pressure difference (AP) standard, which requires the AP not to exceed 49 Pa. Test results showed a maximum value of 73 Pa/cm², indicating the masks did not provide the intended physical barrier effectively against pathogens and particulate matter as required for medical use. The recall is overseen by the National Medical Products Administration (NMPA) and its provincial departments, which regulate medical devices in China. In response to this non-compliance, Shaoyang Qiankangyi Medical Device Co., Ltd. established a Product Recall Leadership Team. The company's sales department is responsible for disseminating recall information to all affected distributors through various communication channels like telephone, fax, and email. Affected products are required to be segregated and stored in a dedicated warehouse. A quality evaluation will determine the final disposition of the recalled items. Products found unsuitable for use will be destroyed under the supervision of the drug regulatory authority. Conversely, any products deemed acceptable after re-evaluation may be approved for continued sale by the same regulatory body. This recall ensures that only products meeting safety and performance standards are available for medical applications.