China NMPA Product Recall - Disposable ECG electrodes

Covidien Medical Devices International Trading (Shanghai) Co., Ltd., part of Medtronic, initiated a voluntary Class III recall for specific batches of its Kendall™ disposable ECG electrodes in China, reported on August 20, 2015. The primary issue was an inaccurate shelf-life label. Products were incorrectly labeled with a "3-year" expiration date, which deviated from the "2-year shelf life" approved under Chinese regulatory registration. This mislabeling, while not impacting the product's performance or safety, constituted a non-compliance with the country's medical device regulations. The recall was conducted under the oversight of the National Medical Products Administration (NMPA). The recall encompassed four product models (31118733, 31112496, 31050522, 31499224), affecting approximately 13.78 million units sold in China across numerous specified batch numbers. As a corrective action, the company instructed customers via letters to identify and return all affected inventory to Covidien.