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, as reported to the National Medical Products Administration (NMPA) on September 4, 2017. The recall stemmed from a critical quality issue: the masks failed to meet the required pressure difference (AP) standard. Regulatory guidelines mandate that the pressure difference should not exceed 49 Pa; however, sampled products exhibited a maximum value of 73 Pa/cm², indicating a deficiency in their design or manufacturing that could affect breathability or protective capabilities. The company produced 13,680 packages of the affected masks (registration number 湘械注准20162640039), with 5,670 packages sold in Changsha City, China. In response, Shaoyang Qiankangyi established a Product Recall Leadership Team. The sales department was tasked with promptly notifying all relevant distributors through various communication channels. Recalled products are to be segregated and stored in a dedicated warehouse. Items determined to be unsalable after quality assessment will be destroyed under the supervision of the drug regulatory authority. Conversely, any products deemed acceptable after re-evaluation may be released for sale, contingent on approval from the regulatory body. This recall ensures adherence to NMPA quality and safety standards for medical devices.