China NMPA Product Recall - Medical electronic thermometer

Beijing Kangzhu Medical Device Co., Ltd. initiated a voluntary Class III medical device recall for its medical electronic thermometers following a sampling inspection in Beijing. Reported on April 22, 2019, the inspection revealed that certain product batches, including identification number 13105190301, failed to meet the established product standard. Specifically, "Item 6.1q) of the YZB/京1174-2012 'KD3 Series Medical Electronic Thermometer' medical device registration product standard" was not satisfied, indicating a critical non-conformance related to product requirements. Under the regulatory framework of the National Medical Products Administration (NMPA), Beijing Kangzhu was required to implement corrective actions. The recall involved affected product models like KD3314, totaling 23,000 units produced, with 18,337 units having been sold in China. The company's required action was to retrieve both sold and unsold products, returning them to the factory for relabeling to ensure compliance with the necessary specifications and rectify the identified product standard violation.