China NMPA Product Recall - Heated Breathing Circuit

On March 28, 2019, Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Heated Breathing Circuit. This action was prompted by the identification of a significant product defect: the potential for the breathing tubing to crack during use. Should this cracking occur, it would lead to air leakage, which could negatively impact the effectiveness of patient ventilation and compromise patient safety. The recall was reported under the regulatory framework of the National Medical Products Administration (NMPA) of China, with the Shanghai Food and Drug Administration also noting the product's registration. Dräger Medical Devices (Shanghai) Co., Ltd. proactively reported this issue. As a required action, the company provided specific details regarding the affected product models, specifications, and batch numbers in an accompanying "Medical Device Recall Event Report Form." This voluntary recall highlights the company's commitment to ensuring product safety and adherence to medical device regulations.