China NMPA Product Recall - Electronic blood pressure monitor

Dongguan Senpu Industrial Co., Ltd. initiated a voluntary Class III recall of its electronic blood pressure monitors (models ePA-10B4, PA-10, ePA-09B4, Registration No. 20172201707) in China. This action, reported on August 8, 2019, and published by the National Medical Products Administration (NMPA) on August 15, 2019, addresses a significant packaging omission. The primary issue was the insufficient information on the product's outer packaging, specifically the absence of applicable arm circumference details. This lack of information was deemed a violation of regulatory requirements for medical device labeling. The recall affects 1000 units from batch 18091332, with 850 units already sold within China. As the identified issue does not compromise the product's performance or safety, Dongguan Senpu Industrial Co., Ltd. is implementing a corrective action through an "information notification method." This involves formally communicating the missing arm circumference information in writing to all affected retailers and end-users. This measure aims to ensure that customers are fully aware of the product's intended use parameters, aligning with NMPA's framework for consumer safety and product transparency.