China NMPA Product Recall - ECG monitoring electrodes

On October 16, 2020, Minnesota Mining Manufacturing (Shanghai) International Trading Co., Ltd. (3M) initiated a voluntary Class II recall concerning certain batches of its ECG monitoring electrodes. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a critical issue: a risk of corrosion in the electrodes' sensing element. This corrosion poses a significant safety concern as it could impair device functionality during emergency defibrillation. Specifically, it may lead to delayed, poor, or absent tracking responses, potentially impacting timely and effective cardiac treatment. While 3M has received only a very limited number of reports of sensor corrosion and no associated patient injuries or complications, the company is taking proactive measures. The required action is a voluntary recall of the affected products to minimize potential risks to patient safety. This ensures the reliability of cardiac function testing and treatment. Detailed information regarding specific models, specifications, and batches of the recalled products is available in the accompanying "Medical Device Recall Event Report Form."