China NMPA Product Recall - Artificial Heart-Lung Machine - Heat Exchange Water Tank

Maquet (Shanghai) Medical Equipment Co., Ltd., the China-based responsible unit for MAQUET Cardiopulmonary AG, initiated a voluntary recall for specific HCU40 Heart-Lung Machine - Heat Exchange Water Tank units. This action, reported by the National Medical Products Administration (NMPA) on January 13, 2017, stemmed from the company's revision of cleaning and disinfection procedures for the medical device. The core issue identified was the potential for atypical mycobacteria contamination within the tank if previous disinfection protocols were followed, posing a patient safety risk. The recall was formally reported by the company on December 27, 2016. To rectify this concern, Maquet developed new standard and advanced disinfection methods. The recall specifically targets HCU40 units with serial numbers below 90441000, affecting 44 units imported to China out of a global total of 51. The required actions include issuing a comprehensive "Recall Notice" to all affected users. Furthermore, authorized Maquet service personnel are dispatched to hospitals to upgrade the heat exchange water tanks on site. Crucially, a revised instruction manual is being provided, and users are receiving thorough training on the updated cleaning and disinfection procedures to ensure proper device maintenance and enhance patient safety in cardiac surgery settings. This proactive measure underscores the company's commitment to mitigating potential health risks.