China NMPA Product Recall - Disposable ECG electrodes

On September 30, 2021, Minnesota Mining Manufacturing (Shanghai) International Trading Co., Ltd., commonly known as 3M, initiated a voluntary Class II recall of its disposable ECG monitoring electrodes (Registration Certificate No.: 20162211927). This action was announced under the regulatory oversight of the National Medical Products Administration (NMPA) in China. The primary issue prompting the recall is a potential defect where the carbon sensor in affected batches of electrodes may break at the carbon snap button. This malfunction renders the electrode unusable, preventing the proper initiation of an electrocardiogram and requiring immediate replacement. While 3M has acknowledged receiving complaints related to this issue, the company has confirmed that no injuries or complications have been reported to date. The voluntary recall was undertaken by 3M to proactively mitigate any potential impact on customers and ensure the continued safety and efficacy of medical devices in circulation. Further specifics regarding the affected product models, specifications, and batch numbers are provided in the comprehensive "Medical Device Recall Event Report Form."