China NMPA Product Recall - Integrated membrane oxygenator, arterial filter, and venous blood storage device

On May 12, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Maikewei (Shanghai) Medical Equipment Co., Ltd. This recall involves critical medical devices, specifically integrated membrane oxygenators, arterial filters, and venous blood storage devices, which are essential components used in medical procedures. The company

’s decision was prompted by findings during routine VKMO validation testing, which revealed a potential risk of breakage in the sterile packaging of an accessory cap. Such a defect could compromise the sterility of the device, posing a potential health risk to patients. Maikewei (Shanghai) Medical Equipment Co., Ltd. emphasized that this proactive measure was taken in a responsible manner to ensure product safety and customer well-being, even though no complaints of serious injury or death directly related to this packaging issue have been reported. The recall applies to devices under Registration Certificate No.: 国械注进20163454677. As part of the required actions, the company has made available a "Medical Device Recall Event Report Form," which provides comprehensive details regarding the specific models, specifications, and batch numbers of the affected products, guiding healthcare providers and consumers on further steps. This incident underscores the stringent quality control standards expected within the medical device industry and the importance of swift regulatory action to maintain public health.