China NMPA Product Recall - thermometer

The National Medical Products Administration (NMPA) publicly announced a voluntary recall initiated by Hongxing Zhengxing Medical Instrument Factory, detailed in a notice dated June 12, 2017. This recall, reported to the Hunan Provincial Food and Drug Administration on April 14, 2017, addresses a significant quality concern with the company's manufactured thermometers. The core issue cited for the recall is the presence of "excessively thick scale lines" on the devices. This manufacturing defect contravenes established general performance standards, which specify a maximum scale line thickness of 0.3mm, indicating a deviation from expected product quality and accuracy. The recall specifically impacts 10,000 units of "Triangular Rod" thermometers from batch number 20160418. Although initially stated as Class III, the recall level was also designated as "Ordinary," signifying a situation where the probability of serious adverse health consequences is remote. As part of the required corrective actions, Hongxing Zhengxing Medical Instrument Factory is systematically recalling all affected products from its distribution network. The company has committed to replacing these faulty thermometers based on the quality assurance agreements established with its various distributors. This voluntary action underscores the manufacturer's responsibility to uphold product quality and ensure the safety and efficacy of medical instruments, aligning with NMPA's regulatory oversight for medical devices within China.