China NMPA Product Recall - Arm-type electronic blood pressure monitor

Shenzhen Lezhongxing Technology Co., Ltd. initiated a voluntary Level III recall of its Arm-Type Electronic Blood Pressure Monitors, specifically model LZX-B1681, following a determination that the products failed to meet certain labeling standards. The recall, publicly announced by the National Medical Products Administration (NMPA) on November 6, 2018, primarily affects units from production batch PC20180105, with 999 out of 1000 produced units sold within China. The main issues identified were two labeling deficiencies. Firstly, the product's single packaging, a color box, failed to specify the applicable arm circumference, which is crucial for correct product usage. Secondly, the production date was omitted from the product nameplate label. These issues were noted not to impact the product's performance or safety directly. Under the guidance of the NMPA's regulatory framework for medical device recalls, Shenzhen Lezhongxing Technology Co., Ltd. implemented a corrective action plan. This involved using an "information notification method" to communicate the missing details in writing to both distributors and end-users. This measure aimed to ensure transparency and provide essential product information that was inadvertently left off the original labeling.