China NMPA Product Recall - Heat exchange water tank system

Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Heat Exchange Water Tank Systems (models IT (S3) and 3T), manufactured by Sorin Group Deutschland GmbH. This action, reported to the National Medical Products Administration (NMPA) on February 8, 2017, was prompted by notifications from U.S. regulatory bodies, including the FDA and CDC, issued on October 13, 2016. The central issue is the potential generation of Mycobacterium tuberculosis (NTM), specifically *Mycobacterium chimera*, during the use of these systems. These water tank systems are integral for temperature control during extracorporeal perfusion surgeries, utilized with artificial heart-lung machines (S5/C5/S3/SC models), and the contamination presents a significant patient safety risk. The recall impacts 736 units imported and sold in China, identified by serial numbers such as 16S0XXXX and 16S1XXXX. Corrective actions include issuing on-site safety reports to users, distributing an updated Field Safety Notice, and requiring all users and distributors to return signed Customer Response Forms to ensure compliance and mitigate potential health risks from the affected devices.