# China NMPA Product Recall - Heat exchange water tank system

Source: https://www.keypedia.com/records/china_product_recall/sorin-group-deutschland-gmbh/72713ba4-67dd-4904-854c-e08634a4bd83
Source feed: China

> China NMPA product recall for Heat exchange water tank system by Sorin Group Deutschland GmbH published March 17, 2017. Recall level: Level II. Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Heat Exchange Water

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Sorin Medical (Shanghai) Co., Ltd. voluntarily recalls heat exchange water tank systems.
- Company Name: Sorin Group Deutschland GmbH
- Publication Date: 2017-03-17
- Product Name: Heat exchange water tank system
- Recall Level: Level II
- Recall Reason: On October 13, 2016, the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued several notices regarding Mycobacterium tuberculosis (NTM) generated during the use of heat exchange tank systems. A CDC Morbidity and Mortality Weekly Report (“MWWR”) article described genomic analysis of samples obtained from patients with NTM infection caused by mycobacterial chimeras. As stated in the MWWR, the data used in that article is not up-to-date; however, it confirms conclusions previously reached by Haller et al. in April 2016. Based on the latest information released by the U.S., LivaNova issued an updated field safety advisory, proactively communicating LivaNova's recommended actions to all relevant agencies, agents, and end-users.
- Discovering Company: Sorin Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Sorin Group Deutschland GmbH
- Summary: 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.

Company: https://www.keypedia.com/companies/sorin-group-deutschland-gmbh/ec92d291-2da5-417e-a019-f318efa3d5ae