# China NMPA Product Recall - Artificial heart-lung machine - heat exchange water tank; heart-lung bypass heat exchange water tank

Source: https://www.keypedia.com/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/70f1fd6c-ef0c-4c5d-8ddf-753ec1ef9b9d
Source feed: China

> China NMPA product recall for Artificial heart-lung machine - heat exchange water tank; heart-lung bypass heat exchange water tank by Maikewei (Shanghai) Medical Equipment Co., Ltd. published August 30, 2021. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its HCU40 c

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling the heat exchange water tank for artificial heart-lung machines (cardiopulmonary bypass heat exchange water tank).
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2021-08-30
- Product Name: Artificial heart-lung machine - heat exchange water tank; heart-lung bypass heat exchange water tank
- Recall Level: Level 2 Recall
- Recall Reason: The issue involves problems discovered by the manufacturer regarding the HCU40's internal three-way valve for regulating hot and cold water, which experienced an increased failure rate due to improper disinfection or descaling operations.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its HCU40 cardiopulmonary bypass machine's heat exchange water tank and other related cardiopulmonary bypass heat exchange water tanks. This action was announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 30, 2021. The affected devices are identified by registration numbers CFDA (Imported) 2014 No. 2452038 and CFDA Import Registration No. 20182451979. The document indicates a recall, but does not specify the particular issues or violations that prompted this action. A Class II recall typically signifies that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company is required to execute this voluntary recall, addressing specific product models, specifications, and batches, with additional details expected in the official "Medical Device Recall Event Report Form." This action underscores compliance with regulatory standards set by the NMPA and local authorities to ensure medical device safety.

Company: https://www.keypedia.com/companies/maikewei-shanghai-medical-equipment-co-ltd/77310e7c-a692-4918-a052-23f3348af2e9