China NMPA Product Recall - Centrifugal pump for cardiopulmonary circulation system

Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its centrifugal pumps designed for cardiopulmonary circulation systems, as reported on December 7, 2017. This action was conducted under the oversight of the National Medical Products Administration (NMPA) in China. The primary issue prompting the recall is the potential for air bubbles in the affected product to enter a patient's body before the tubing clamp fully closes. While this is noted as a "very small possibility," the company is taking proactive measures to address the potential safety concern. The specific product involved has Registration No.: 20133455493(Revised). Detailed information regarding the models, specifications, and batch numbers of the affected devices are included in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the manufacturer's commitment to patient safety and adherence to regulatory requirements, ensuring that potentially problematic medical devices are removed from circulation to prevent any adverse health consequences.