China NMPA Product Recall - Blood concentrator

MAQUET Cardiopulmonary GmbH has initiated a voluntary Class II recall of its blood concentrators, as reported by MAQUET (Shanghai) Medical Equipment Co., Ltd. This action, publicized by the National Medical Products Administration (NMPA) on January 23, 2024, stems from the inadvertent use of expired components during the manufacturing process of the affected medical devices. This manufacturing deviation potentially impacts the product's quality and safety. The NMPA, operating under its regulatory framework, has categorized this event as a Class II recall, signifying that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. As a required action, the company is systematically recalling the identified blood concentrators. Specific details concerning product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form" referenced in the NMPA's announcement. This proactive measure by MAQUET aims to ensure patient safety and uphold product quality standards.