China NMPA Product Recall - Heat exchange water tank system

Sorin Medical (Shanghai) Co., Ltd., the Chinese representative for manufacturer Sorin Group Deutschland GmbH, initiated a voluntary Class II recall of its Heat Exchanger Tank Systems. This action, reported to the National Medical Products Administration (NMPA) in February 2017 and published in March 2017, stems from notifications by US regulatory agencies, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The core issue, identified by US authorities in October 2016, involves the potential generation of Mycobacterium tuberculosis (NTM), including Mycobacterium chimera, within these critical medical devices. These systems are integral to artificial heart-lung machines, controlling water temperature during extracorporeal perfusion surgery. The recall impacts models IT (S3) and 3T, with 736 units sold in China and a global reach. Corrective actions involve Sorin Medical (Shanghai) notifying all relevant agencies, agents, and end users about the updated Field Safety Notice. Distributors are tasked with communicating LivaNova's (a related entity) action recommendations and ensuring the return of signed Customer Response Forms. This comprehensive recall aims to address the identified contamination risk and ensure patient safety.