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

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.