China NMPA Product Recall - Tracheal Tubes and Accessories
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The National Medical Products Administration (NMPA) announced an update regarding a voluntary recall initiated by Teleflex Medical, Inc., USA, concerning certain tracheal tubes and accessories. The recall, initially declared in 2019 and categorized as a Level 1 event due to its high potential for serious health impact, was reported by Teleflex Medical Devices Trading (Shanghai) Co., Ltd. The primary issue identified is the potential for 15mm Hilton connectors to detach from tracheal tubes in specific product batches, posing a significant risk to patient safety and device functionality. Under the NMPA's regulatory framework, the affected products are registered under certificate numbers 国械注进20172661667 and 国食药监械(进)字2013第2665602号. The latest announcement, dated August 28, 2019, specifies a change in the quantity of recalled devices. Required actions include the ongoing voluntary recall, with comprehensive details on product names, models, specifications, and batch numbers available in the 'Medical Device Recall Event Report Form'.
- Company
- Teleflex Medical
ID · 03c42292-74ca-420b-98e5-6d25391707b6