# China NMPA Product Recall - Heat exchange water tank system

Source: https://www.globalkeysolutions.net/records/china_product_recall/sorin-group-deutschland-gmbh/d5b70fa6-449c-4689-b001-bf5a862e5ebe/
Source feed: China

> China NMPA product recall for Heat exchange water tank system by Sorin Group Deutschland GmbH published April 06, 2017. Recall level: Level II. Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class II recall of 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: 2017-04-06
- 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 MWWR, the data used in this article is not the most recent; however, it confirms conclusions previously reached by Haller et al. in April 2016.
- 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 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.

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