China NMPA Product Recall - Electronic thermometer

Beijing Luyuan Hengtai Medical Device Co., Ltd. initiated a voluntary Level III recall for its electronic thermometers, specifically model LY-302C, batch number 1810030. This action, reported on September 24, 2019, and publicized by the National Medical Products Administration (NMPA) on October 8, 2019, addresses a non-compliance issue concerning product labeling. The core violation involves an error in item 6.1, "External Markings of Equipment or Equipment Components," which is solely a labeling deficiency and does not impact the product's safety or effectiveness. To meet regulatory requirements, the company outlined several corrective actions. These include issuing warning notices to distributors for the return of affected products. Internally, the company will rectify the products by adding the required clause 6.11 to their labeling. Furthermore, an internal assessment meeting will be held, and relevant personnel will receive training. Finally, all returned products will have their labels replaced with compliant information and undergo re-inspection before being resent to the market.