# China NMPA Product Recall - Membrane oxygenators, consumables for autologous blood recovery devices, centrifuge pump heads, and consumables for blood recovery separators.

Source: https://www.globalkeysolutions.net/records/china_product_recall/amsino-medical-shanghai-co-ltd/0d25271b-373a-4640-a12d-b6b04e8b02fd/
Source feed: China

> China NMPA product recall for Membrane oxygenators, consumables for autologous blood recovery devices, centrifuge pump heads, and consumables for blood recovery separators. by Amsino Medical (Shanghai) Co., Ltd. published October 18, 2018. Recall level: Level 3 Recall. Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class III recall in October 2018, overseen 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Sorin Medical (Shanghai) Co., Ltd. has voluntarily recalled its membrane oxygenators and other products.
- Company Name: Amsino Medical (Shanghai) Co., Ltd.
- Publication Date: 2018-10-18
- Product Name: Membrane oxygenators, consumables for autologous blood recovery devices, centrifuge pump heads, and consumables for blood recovery separators.
- Recall Level: Level 3 Recall
- Recall Reason: On some products, the product registration certificate number on the sterilization packaging and outer packaging, even after the product registration certificate was updated, was not promptly replaced with the new product registration certificate number.
- Discovering Company: Sorin Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Amsino Medical (Shanghai) Co., Ltd.
- Summary: Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class III recall in October 2018, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall involves several medical devices, including membrane oxygenators, autologous blood recovery device consumables, pump heads, and blood recovery separator consumables. The primary issues prompting this action were identified in certain product batches. Firstly, there were concerns regarding the sterilization packaging of some affected items. Secondly, and significantly, the Chinese labels on the outer packaging of some products displayed an outdated product registration certificate number. This critical information was not updated in a timely manner following the renewal of the products' official registration certificates. This voluntary recall mandates the company to address these non-compliance issues to ensure product safety and accurate labeling in accordance with regulatory standards. The NMPA's involvement highlights the regulatory framework governing medical device manufacturing and distribution in China, emphasizing adherence to updated certification and packaging integrity. The Level III classification indicates a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences.

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