China NMPA Product Recall - upper arm electronic blood pressure monitor

The National Medical Products Administration (NMPA) announced on January 17, 2019, that Jiaxing Zhongfa Medical Device Co., Ltd. initiated a voluntary Class III recall of its upper arm electronic blood pressure monitors (Registration Certificate No.: Zhexiezhuzhun 20162200265). This action followed a national medical device supervision and spot check which revealed that the products, specifically model 2F-808, batch ZF180400001, numbering 750 units, failed to meet their registered or filed product technical requirements. The primary issue identified was suspected non-compliance with modification standards, leading to devices that did not conform to established registration or filing criteria. As a result, Jiaxing Zhongfa Medical Device Co., Ltd. is mandated to take several corrective actions under the NMPA's regulatory framework. These include promptly issuing recall notices to all affected customers for this specific batch, conducting re-sampling and self-inspection of all inventory products to ensure compliance, and fully cooperating with regulatory authorities throughout the recall process and any subsequent investigations. This measure ensures public safety and adherence to medical device standards.