China NMPA Product Recall - Disposable medical masks

Xinxiang Jinhuan Medical Device Co., Ltd. initiated a voluntary Level III recall of 80,000 units of its disposable medical masks (Batch 020040613), effective November 10, 2020, under the oversight of China's National Medical Products Administration (NMPA). The recall was prompted by a provincial medical device sampling inspection that identified the masks as non-compliant with ventilation resistance standards. Specifically, the masks exhibited a pressure difference of 53Pa, exceeding the national regulatory limit of 49Pa, rendering them substandard. The company's investigation revealed that all 78,000 units distributed within China from the affected batch had already been consumed by customers, with no remaining inventory to retrieve. As a corrective action, Xinxiang Jinhuan Medical Device Co., Ltd. committed to addressing the root cause of the non-compliance. The company suspects the issue stemmed from using BFE99 grade meltblown fabric instead of the BFE95 grade, which had previously yielded compliant test results. Subsequent production will utilize the BFE95 grade fabric to ensure adherence to national quality and safety standards. This recall highlights the importance of rigorous quality control in medical device manufacturing.