China NMPA Product Recall - Tracheal Tubes and Accessories

On August 6, 2019, the National Medical Products Administration (NMPA) announced a Level 1 voluntary recall initiated by Teleflex Medical, Inc. The recall, reported by Teleflex Medical Devices Trading (Shanghai) Co., Ltd., concerns specific batches of tracheal tubes and accessories. The primary issue identified is the potential detachment of 15mm Hilton connectors from these tracheal tubes. This defect poses a significant safety risk, leading to the classification of the recall as Level 1, indicating a high probability of serious adverse health consequences or death. The affected products are identified under registration certificates 国械注进20172661667 and 国食药监械（进）字2013第2665602号. This regulatory action, documented under NMPA Index No. JGXX-2019-10498, mandates the removal of these potentially faulty medical devices from circulation. Teleflex Medical, Inc. is responsible for implementing this recall to safeguard patient well-being and ensure compliance with medical device safety standards set by the NMPA. Further details regarding specific models, specifications, and batch numbers are contained within the 'Medical Device Recall Event Report Form' attachment.