# China NMPA Product Recall - Cardiopulmonary exchange water tank

Source: https://www.globalkeysolutions.net/records/china_product_recall/amsino-medical-shanghai-co-ltd/c94ab8ec-1afa-471c-9c7b-a95c03e4e04f/
Source feed: China

> China NMPA product recall for Cardiopulmonary exchange water tank by Amsino Medical (Shanghai) Co., Ltd. published December 11, 2018. Recall level: Level 3 Recall. Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Fenjiu cardiopulmon

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Sorin Medical (Shanghai) Co., Ltd. voluntarily recalls cardiopulmonary bypass water tanks
- Company Name: Amsino Medical (Shanghai) Co., Ltd.
- Publication Date: 2018-12-11
- Product Name: Cardiopulmonary exchange water tank
- Recall Level: Level 3 Recall
- Recall Reason: In a few devices, after a period of clinical use, the hydrogen peroxide concentration rapidly drops to zero within a day. In devices where hydrogen peroxide is rapidly lost, the nickel coating on the coils degrades, exposing copper. Investigations revealed that the rapid decrease in hydrogen peroxide concentration is caused by a reaction between the exposed copper and the oxygen in the hydrogen peroxide.
- Discovering Company: Sorin Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Amsino Medical (Shanghai) Co., Ltd.
- Summary: Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Fenjiu cardiopulmonary resuscitation devices, specifically Cardiopulmonary Exchange Water Tanks. This action, reported to the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (as per Medical Device Recall 2018-276), was announced on December 11, 2018. The recall stems from a critical issue identified in a subset of the affected products after clinical use. Investigations revealed a rapid and premature drop in hydrogen peroxide concentration to zero within one day. Further analysis linked this issue to the degradation of the nickel coating on the device's coils, leading to the exposure of copper. The rapid loss of hydrogen peroxide was subsequently attributed to a chemical reaction occurring between the exposed copper and the hydrogen peroxide solution. This defect potentially compromises the device's intended function and patient safety. Sorin Medical (Shanghai) Co., Ltd. has issued a formal recall notice, detailing product models, specifications, and batch numbers in an attached Medical Device Recall Event Report Form, to facilitate the removal of these devices from circulation and mitigate potential risks.

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