China NMPA Product Recall - Multifunctional electrode (accessory for defibrillator monitor)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary Level III recall of its Multifunctional Electrode, a defibrillator accessory. This action, reported to the National Medical Products Administration (NMPA) on August 21, 2017, was prompted by a significant labeling error. The Chinese label on the outer packaging of the multifunctional electrode pad contained an incorrect "Product Name." The recall addresses products identified under NMPA Approval No. 20133211733. While specific inspection dates are not provided, the company is taking proactive steps to rectify this product identification and labeling inaccuracy, which is crucial for medical device regulatory compliance. Further details regarding affected product models, specifications, and batch numbers are available in the "Recall Event Report Form" provided by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. This voluntary recall emphasizes the critical importance of accurate labeling for medical devices to ensure proper product identification and user safety.