China NMPA Product Recall - Disposable medical masks

Henan Yidejian Medical Supplies Co., Ltd. initiated a voluntary Level III recall of its Disposable Medical Masks, as reported to the National Medical Products Administration (NMPA) and the Henan Provincial Drug Administration on November 17, 2020. This action followed a random inspection by the Henan Provincial Medical Device Inspection Institute. The primary issue identified was the non-compliance of the mask straps' tensile strength. Specifically, the breaking strength at the connection point between each mask strap and the mask body failed to meet the required minimum of 10N. The affected product was specified as Model Type A, Large, with batch number 37200408. A total of 200,000 units of the non-compliant masks were sold in China. Although a recall was initiated, the company confirmed that the entire batch had already been consumed, resulting in a recall quantity of zero. In response to the violation, Henan Yidejian Medical Supplies Co., Ltd. has committed to analyzing the root causes of the non-compliance and implementing corrective and preventive measures. These actions aim to prevent similar quality control issues from recurring, ensuring future product batches meet established regulatory standards for medical devices. The company's voluntary recall demonstrates adherence to medical device safety regulations under the NMPA framework.