China NMPA Product Recall - Medical surgical masks

The National Medical Products Administration (NMPA) announced a Level III voluntary recall initiated by Henan Cheng'an Medical Technology Co., Ltd. for a batch of its medical surgical masks. This recall, formally reported by the company on November 15, 2020, and publicly announced by the NMPA on November 24, 2020, addresses a significant quality issue. The primary violation identified was the substandard breaking strength at the connection point between the mask strap and the mask body, failing to meet required tensile strength specifications. The affected product, specifically medical surgical masks from production batch number 20032622, totaling 5000 units, was intended for clinical medical personnel during invasive procedures to provide a physical barrier against pathogens. Upon discovering the non-compliance, Henan Cheng'an Medical Technology Co., Ltd. immediately conducted an inspection of its finished product warehouse, only to find that the entire problematic batch had already been sold. As part of its corrective actions under the NMPA's medical device recall framework, the company's sales department promptly issued recall letters to all affected customers. However, customer responses indicated that the recalled products had already been fully utilized, leaving no remaining inventory for return. The company fulfilled its reporting obligations to the Provincial Food and Drug Administration.