China NMPA Product Recall - Medical physical heating device, artificial heart-lung machine - heat exchange water tank

Maikewei (Shanghai) Medical Equipment Co., Ltd., representing MAQUET Cardiopulmonary AG, initiated a voluntary Level III recall reported to the National Medical Products Administration (NMPA) on August 29, 2016, following an event report on July 22, 2016. The recall involves Medical Physical Heating Devices and Cardiopulmonary Respirator - Heat Exchange Water Tanks, including models HU35, HCU20, HCU30, and HCU40. The central issue was the discovery of mycobacterial and other bacterial contamination in the water within the heat exchange tanks. While the water system does not directly contact patients, there is a recognized risk of bacteria spreading to other equipment parts or the user environment. No patient infections or adverse events have been reported in connection with this contamination.

Under the NMPA's regulatory guidelines, the company's required actions include the global recall of affected units. To proactively enhance device safety, Maikewei (Shanghai) Medical Equipment Co., Ltd. will revise the disinfection procedures for these systems. Additionally, a "User Safety Notice" is being distributed to all customers, outlining the necessary corrective actions and detailing the timeline for the release of the updated disinfection protocols, ensuring a proactive response to potential risks.