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

The National Medical Products Administration (NMPA) announced on November 6, 2018, that Shenzhen Lezhongxing Technology Co., Ltd. initiated a voluntary Level 3 recall for its arm-type electronic blood pressure monitors. This action followed the company's own testing, which revealed that certain product labeling failed to meet regulatory standards. The primary issues identified with the affected products, specifically model LZX-B1681 from production batch PC20180105 (totaling 1000 units, with 999 sold in China), involved deficiencies in product labeling. Firstly, the single packaging did not specify the applicable arm circumference. Secondly, the production date was absent from the product nameplate label. According to the report submitted to the provincial Food and Drug Administration on October 26, 2018, Shenzhen Lezhongxing Technology Co., Ltd. stated that these labeling omissions did not compromise product performance or safety. Consequently, the company is implementing an 'information notification method' by formally advising distributors and users in writing about the missing labeling details.