China NMPA Product Recall - Double-lumen endotracheal intubation

The National Medical Products Administration (NMPA) issued a notice on March 18, 2014, detailing a voluntary recall of double-lumen endotracheal tubes manufactured by Teleflex Medical (Ireland). The recall was initiated by Teleflex Medical on March 4, 2014, after reports concerning the Rusch Bronchopart® double-lumen endotracheal tube (model 116200, Registration No.: CFDA (Imported) No. 20122662267 (Revised)). Teleflex Medical Devices Trading (Shanghai) Co., Ltd. formally reported the recall to the NMPA on March 7, 2014. The primary issue identified is that the cuff on one side of the tubes inflates improperly, leading to a potential failure in right lung isolation. This defect poses a serious risk to patient safety, including decreased blood oxygen saturation and loss of volatile anesthetic, which may necessitate urgent reintubation. The NMPA is overseeing the management of this global recall, which involved 2509 units sold in China. Required actions for affected parties include immediately inspecting and isolating the defective products, ceasing their use, informing all relevant personnel about the recall, and returning all remaining stock to the company.