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

Dongguan Fudakang Industrial Co., Ltd. has initiated a voluntary, Level III recall for 150 units of its arm-type fully automatic electronic blood pressure monitors, specifically model FT-A11-2, batch 1505. This recall, affecting products sold in China, was reported to the National Medical Products Administration (NMPA) on August 14, 2019. The basis for this action stemmed from an inspection report, dated August 7, 2019, issued by the Shanghai Medical Device Inspection Institute. The report identified non-compliance regarding the product's packaging and instruction manuals. Specifically, these components did not meet the requirements of standard YY0670-2008, sections 4.2.2 and 4.2.3, respectively, due to incorrect labeling information. It was explicitly stated by the company that these issues were related solely to labeling and did not compromise the product's safety or effectiveness. To address these regulatory discrepancies, Dongguan Fudakang Industrial Co., Ltd. is undertaking corrective actions. These include supplementing the recalled product packaging and instruction manuals with the necessary information to ensure full adherence to the YY0670-2008 standard. This proactive measure highlights the company's commitment to maintaining regulatory compliance and product integrity under the NMPA framework.