# China NMPA Product Recall - Heat exchange water tank system

Source: https://www.globalkeysolutions.net/records/china_product_recall/sorin-group-deutschland-gmbh/f68f5ddc-7433-432c-a407-2dd8cb129a79/
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., the Chinese representative for manufacturer Sorin Group Deutschl

---

## 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 Mycobacterium chimera. As stated in MWWR, the data used in this 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., 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.

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