China NMPA Product Recall - Non-invasive automatic blood pressure monitor

Wuhan Kangjier Medical Technology Co., Ltd. initiated a voluntary Level III recall of its non-invasive automatic blood pressure monitors (model KG-D1, batch SC20160501), affecting four units sold in China. This action, published by the National Medical Products Administration (NMPA) on September 25, 2017, followed findings during national medical device spot checks. The primary issue identified was that the product's instruction manual labeling did not comply with national industry standards. The company conducted a risk assessment, concluding that the identified labeling discrepancies did not pose any threat to human health. In response, Wuhan Kangjier Medical Technology Co., Ltd. implemented corrective actions. These included issuing a warning letter to its sales unit, Hubei Zhongbao Pharmaceutical Co., Ltd., outlining recall requirements and handling methods. Furthermore, the company has corrected the instruction manual for this product, which is now undergoing re-registration with the NMPA. The recall report was officially submitted on September 15, 2017.