China NMPA Product Recall - centrifugal pump

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its centrifugal pumps, publicly announced on July 19, 2021. This action is an expansion of a previous recall from 2019, incorporating an additional four units imported into China. The primary issue identified during the company's internal flow testing was a loose ODU plug connection in the coaxial cable connected to the centrifugal pump drive unit. This defect can lead to poor pin contact, which compromises the accurate transmission of flow measurement data. As a result, the flow value displayed on the centrifugal pump control base may fluctuate, potentially affecting the device's performance and patient care. Under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, Maikewei is undertaking this recall to ensure product safety and uphold its commitment to customers. Affected centrifugal pumps (CFDA (Imported) 2014 No. 2453515; CFDA Import Registration No. 20193102117) are subject to this action, with specific details on models and batches provided in the "Medical Device Recall Event Report Form."