China NMPA Product Recall - Fully automatic electronic blood pressure monitor

Nakajima Medical Instruments (Shenzhen) Co., Ltd. initiated a voluntary Class 3 recall of its Fully Automatic Electronic Blood Pressure Monitors, as reported to the National Medical Products Administration (NMPA) on October 16, 2018. The recall, detailed in a report dated November 1, 2018, and published on November 2, 2018, stems from the product's outer packaging failing to specify the applicable arm circumference (diameter: 5cm-17cm), indicating a non-compliance with standard labeling requirements. The affected products, identified under registration certificate Guangdong Medical Device Registration Certificate 20172200439, include batches CN703AAGU0001-CN703AAGU0050, with 50 units sold in China. Under the NMPA's regulatory framework for medical devices in China, Nakajima Medical Instruments is required to immediately suspend sales of the affected blood pressure monitors. Furthermore, the company must disseminate the recall notice to all relevant operating enterprises and user units. Corrective actions include printing new labels with the correct arm circumference information for affixing to existing product packaging and modifying the overall outer packaging design to ensure full compliance with regulatory standards. This proactive recall aims to address the labeling deficiency and ensure product information accuracy for consumer safety.