China NMPA Product Recall - Medical surgical masks

Zhengzhou Anzhiyuan Medical Device Co., Ltd. initiated a Level III voluntary recall of 6,000 medical surgical masks on November 21, 2020, following an announcement by the National Medical Products Administration (NMPA). The recall was prompted by a random inspection that revealed a significant quality deviation: a batch of masks, specifically production batch number 20200628, failed to meet national pressure difference requirements. The masks exhibited a pressure difference of 60 Pascals (Pa), exceeding the national standard limit of 49 Pa, rendering them non-compliant for their intended use by clinical medical personnel during invasive procedures. The issue potentially compromises the masks' ability to provide an adequate physical barrier against pathogens, microorganisms, and particulate matter. In response, Zhengzhou Anzhiyuan Medical Device Co., Ltd. committed to a series of corrective actions. These include tracing, retrieving, and destroying all affected products from the market. Furthermore, the company plans to rectify the manufacturing process, suspecting the non-compliance was due to the use of BFE99 grade meltblown fabric. Future production will utilize BFE95 grade meltblown fabric, which previously yielded compliant test results, to ensure adherence to established national medical device standards.