China NMPA Product Recall - Heat exchange water tank system, variable temperature water tank system

Linofa (China) Medical Technology Co., Ltd. initiated a voluntary Class II recall of its heat exchange and variable temperature water tank systems. This action, reported by the National Medical Products Administration (NMPA) on April 8, 2019, addresses significant product defects compromising device performance and safety. The identified issues include evaporator coil corrosion, malfunction or performance problems with switching valves, and leakage from both exhaust and drain valves. These critical component failures necessitated the recall of various products, identified by specific registration certificate numbers such as 国械注进20172452137. The regulatory framework for this action involves the NMPA and the Shanghai Food and Drug Administration, under whose oversight these devices were registered. The required action by Linofa is a comprehensive recall to mitigate risks associated with the defective medical devices, ensuring product quality and patient safety standards are maintained.