China NMPA Product Recall - Medical surgical masks

Shijiazhuang Kang'an Medical Device Co., Ltd. initiated a voluntary Level III recall of its medical surgical masks (Registration No.: 冀械注准20152640016, production batch number: November 6, 2018). This action followed findings during the 2019 National Medical Device Supervision and Inspection, overseen by the National Medical Products Administration (NMPA). Sampling conducted at Tianjin Wuqing Renhe Hospital and subsequent testing by the Henan Provincial Medical Device Inspection Institute (Test Report No.: 201900608) revealed that the masks had a substandard pressure difference (Ap) for gas exchange. This critical defect meant the product failed to meet the essential performance requirements outlined in the YY 0469-2011 standard. Upon receiving the inspection report, Shijiazhuang Kang'an Medical Device Co., Ltd. conducted an immediate investigation into the cause. The company promptly issued a recall notification to customers on July 6, 2019, requiring operating units to cease selling and using the affected batch of products and to return them. By July 18, 2019, products were being returned. In addition to the recall, the company committed to implementing corrective actions and strengthening management and control processes within its production operations to prevent recurrence. This regulatory action ensures public safety and adherence to medical device standards.