China NMPA Product Recall - Heat exchange water tank system

Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Heat Exchange Water Tank Systems (models 1T (S3) and 3T) on April 6, 2017, following notifications from U.S. regulatory agencies, including the CDC and FDA, in October 2016. The recall was prompted by the confirmed risk of Mycobacterium tuberculosis (NTM), specifically Mycobacterium chimera, generation during the use of these systems. These devices are critical for controlling temperature during extracorporeal perfusion surgery with artificial heart-lung machines. The main issue identified was patient infection due to contaminated water tank systems, as highlighted by genomic analysis described in the CDC's Morbidity and Mortality Weekly Report and earlier findings in April 2016. The recall applies globally, affecting 736 units imported and sold in China. Under the oversight of the National Medical Products Administration (NMPA) in China, Sorin Medical (Shanghai) Co., Ltd., acting on behalf of manufacturer Sorin Group Deutschland GmbH, implemented several required actions. These included issuing a "Field Recall No." to users and distributing an updated Field Safety Notice with action recommendations to all relevant agencies, agents, and end users. Additionally, users and distributors were required to return signed Customer Response Forms to LivaNova, the entity that issued the updated safety notice. This comprehensive recall aims to mitigate potential health risks associated with the contaminated medical devices.