China NMPA Product Recall - Video laryngoscope system

Shanghai Rubo Trading Co., Ltd., as the responsible unit in China for manufacturer Verathon Incorporated, initiated a voluntary Class II recall of its Video Laryngoscope System, effective August 29, 2016. The recall was prompted by a critical safety concern: the handle blade tip of the affected products exhibited a risk of splitting, potentially leading to intubation failure during medical procedures. This defect could compromise patient safety and the effectiveness of anesthesia intubation, where the device is intended to provide better glottis exposure and improve intubation success rates. The recall specifically impacts AVL Reusable Systems and GVL Reusable Systems, including reusable blades. A total of 155 units sold or imported into China are affected, identified by part numbers such as 0574-0007 and 0574-0001. Under the regulatory oversight of the National Medical Products Administration (NMPA), Verathon Incorporated committed to a corrective action plan. This involves replacing the identified defective part numbers free of charge for all affected customers. This proactive measure aims to mitigate the risk of intubation failure and ensure the safety and reliability of the medical device in clinical settings. The recall event report was dated May 30, 2016.