China NMPA Product Recall - Endotracheal tubes and accessories

Telif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its endotracheal tubes and accessories, with an update published on August 22, 2019, following an initial report to the Shanghai Food and Drug Administration on June 25, 2019. This critical action was prompted by reported complaints detailing an increased incidence of detachment between the 15 mm SHERIDAN connector and the endotracheal tube within specific product batches. Such a malfunction can lead to the disengagement of a patient's breathing circuit, potentially causing insufficient oxygen supply and necessitating urgent medical intervention. Operating under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, the company has expanded the scope of this recall to include an additional 197,484 affected products. The recall encompasses endotracheal tubes and accessories with registration numbers such as CFDA Registration No. 20172661667 and CFDA Import Registration No. 20132665602. As part of its required actions, Telif Medical Devices Trading is updating the reason for the recall and is committed to sending revised customer letters. These letters will inform customers about the expanded issue and outline further necessary measures, ensuring all stakeholders are aware of the risks and corrective steps to safeguard patient safety.