China NMPA Product Recall - Medical physical heating device

The National Medical Products Administration (NMPA) in China announced a Class II voluntary recall initiated by Maquet Cardiopulmonary GmbH, a medical device manufacturer. This recall, reported by Maquet (Shanghai) Medical Equipment Co., Ltd., became publicly accessible on January 31, 2023. The recall targets a specific medical physical heating device, identified by Registration Certificate No. 20162451786. The primary issue necessitating this action is an identified leakage risk in particular models and batches of the physical heating devices. This defect poses a potential safety concern, prompting the manufacturer to take proactive measures within the NMPA's regulatory guidelines to address the issue. As a Class II recall, this designation indicates that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The required action is a voluntary recall by Maquet Cardiopulmonary GmbH to remove the affected products from circulation and minimize any potential risks to patient safety. Detailed information regarding the precise models, specifications, and batch numbers impacted by this recall is available in an accompanying "Medical Device Recall Event Report Form," emphasizing the company's commitment to patient safety and product quality standards.