China NMPA Product Recall - Fully automatic electronic blood pressure monitor

Nakajima Medical Instruments (Shenzhen) Co., Ltd. initiated a voluntary recall of its Fully Automatic Electronic Blood Pressure Monitors, as reported to the National Medical Products Administration (NMPA) on October 16, 2018, and published on November 2, 2018. The recall stems from a non-compliance issue where the product's outer packaging failed to clearly indicate the applicable arm circumference, specified as 5cm-17cm in diameter. This oversight affects 50 units of the product, specifically batch numbers CN703AAGU0001-CN703AAGU0050, which were distributed and sold exclusively within China.

Under the NMPA's regulatory framework, Nakajima Medical Instruments is required to undertake several corrective actions. These include an immediate suspension of sales for the affected blood pressure monitors. The company must also disseminate the recall notice to all relevant operating enterprises and user units to ensure widespread awareness. Furthermore, Nakajima Medical Instruments is mandated to print new labels containing the correct arm circumference information and provide them to operating enterprises for affixing to the product outer packaging. Finally, the company must redesign its product outer packaging to ensure full compliance with current laws and regulations, preventing similar issues in the future. This voluntary recall aims to address the labeling discrepancy and uphold product information standards for consumers.