China NMPA Product Recall - Medical electronic thermometer

Beijing Kangzhu Medical Device Co., Ltd. initiated a voluntary recall of its medical electronic thermometers, specifically batch number 13105190301, on October 8, 2019. This action followed a sampling inspection conducted in Beijing, with findings reported on September 2, 2019. The inspection revealed that the affected thermometers did not meet the specified requirements of item 6.1q, among others, within the medical device registration product standard YZB/京1174-2012 "KD3 Series Medical Electronic Thermometer." The non-compliance was identified under the regulatory oversight of the National Medical Products Administration (NMPA).

In response, Beijing Kangzhu Medical Device Co., Ltd. has implemented a series of corrective measures. These include the issuance of formal notifications to all relevant agents, distributors, and end-users, instructing them to immediately cease the sale and use of the non-conforming products. Furthermore, both sold and unsold products from the identified batch are required to be returned to the manufacturing facility for necessary relabeling to ensure full adherence to the established product standards. This comprehensive recall aims to address the identified product deficiencies and maintain compliance with regulatory expectations.