# China NMPA Product Recall - Heat exchange water tank system

Source: https://www.globalkeysolutions.net/records/china_product_recall/amsino-medical-shanghai-co-ltd/e37565a3-dc00-4721-a6bc-6b5356aeefcb/
Source feed: China

> China NMPA product recall for Heat exchange water tank system by Amsino Medical (Shanghai) Co., Ltd. published June 19, 2017. Recall level: Level 2 Recall. Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its heat exchange water 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Sorin Medical (Shanghai) Co., Ltd. voluntarily recalls heat exchange water tank systems.
- Company Name: Amsino Medical (Shanghai) Co., Ltd.
- Publication Date: 2017-06-19
- Product Name: Heat exchange water tank system
- Recall Level: Level 2 Recall
- Recall Reason: The product carries a risk of bacterial infection.
- Discovering Company: Sorin Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Amsino Medical (Shanghai) Co., Ltd.
- Summary: Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its heat exchange water tank system, as reported by the National Medical Products Administration (NMPA) on June 19, 2017. This recall follows an earlier action in 2015, with the company indicating upgraded measures based on previous experiences. The primary concern prompting this action is the significant risk of bacterial infection associated with the affected products. Operating under the oversight of the NMPA, the company is addressing potential safety hazards to protect public health. The specific recall identifier provided is CFDA (Imported) No. 20132454894 (Updated). While no direct inspection dates are detailed in the announcement, the information signifies an ongoing commitment to product safety and regulatory compliance. As part of the required actions, Sorin Medical is systematically withdrawing the identified heat exchange water tank systems from the market. The recall involves specific models, specifications, and batches, with comprehensive details available in the 'Medical Device Recall Event Report Form' attached to the official NMPA notice. This proactive measure by Sorin Medical aims to mitigate the bacterial infection risk and ensure the safety and efficacy of their medical devices.

Company: https://www.globalkeysolutions.net/companies/amsino-medical-shanghai-co-ltd/d94d650b-fe54-4ea3-b8c0-349a3be33186/