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

Hunan Nuodun Medical Device Co., Ltd. voluntarily initiated a Level III recall for 499 units of its Arm-Type Electronic Blood Pressure Monitors (Registration No.: "湘械注准20182200105"). The recall, announced by the National Medical Products Administration (NMPA) on July 22, 2019, stemmed from a labeling non-compliance. The product's labeling did not meet requirement 4.2 of the YY0670-2008 standard, specifically omitting information related to section 4.2.3. Despite this regulatory labeling issue, the company stated that the product's performance was compliant and posed no threat to human health, noting that the non-compliance was due to an omission in the instruction manual. Required actions for the company included establishing a recall leadership team, notifying distributors through various communication channels, and setting up a dedicated warehouse for recalled items. Products deemed requiring destruction after quality evaluation would be handled under drug regulatory authority supervision, while those deemed salable could continue after approval. The company also committed to a comprehensive self-inspection and rectification plan based on this incident.