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

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/f6d19ade-d5a1-4818-af1b-92d0c4e9ed77/
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 February 22, 2021. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall for its ca

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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: 2021-02-22
- Product Name: Artificial heart-lung machine - heat exchange water tank; heart-lung bypass heat exchange water tank
- Recall Level: Level 2 Recall
- Recall Reason: Vacuum valve leakage problem
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall for its cardiopulmonary bypass machine heat exchange water tanks. This action, reported by the National Medical Products Administration (NMPA) on February 22, 2021, addresses an issue with a leaking vacuum valve in the devices. The company had previously issued a recall for this problem in August 2020. However, during the implementation of that initial recall, it was determined that the corrective measures did not achieve the intended results, prompting the need for a more comprehensive action. As a result, Maikewei (Shanghai) Medical Equipment Co., Ltd. has suspended its prior corrective efforts in the region and has launched a new recall for affected models of the artificial heart-lung machine heat exchange water tank and heart-lung bypass heat exchange water tank. This decision was made to ensure customer safety and product effectiveness. Although no adverse events directly attributable to the vacuum valve leakage have been reported, the company is taking proactive steps to rectify the issue. The specific models, specifications, and batch numbers subject to this recall are detailed in a supplementary Medical Device Recall Event Report Form. This recall highlights the manufacturer's responsibility under NMPA regulations to ensure the safety and efficacy of medical devices, particularly when initial corrective actions prove insufficient.

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