China NMPA Product Recall - Smart blood pressure monitor

Shandong Zhonghong Information Technology Co., Ltd. initiated a voluntary Level III recall of its Smart Blood Pressure Monitors, specifically Batch No. 201706001. This action was reported on December 17, 2018, under National Medical Products Administration (NMPA) Index No. JGXX-2018-11478. The primary issue identified was the absence of "cuff application scope" labeling on the outer packaging of the affected devices. This omission prompted the company to proactively remove the products from the market to ensure compliance with medical device labeling standards. The devices are registered under Lu Medical Device Registration Certificate 20162200498. The required action for Shandong Zhonghong Information Technology Co., Ltd. is the comprehensive withdrawal of the identified batch from distribution. This recall highlights the importance of accurate and complete product information to ensure user safety and adherence to regulatory requirements for medical devices under the NMPA framework. Detailed information regarding affected models and specifications is documented in the "Medical Device Recall Event Report Form."