Device product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
Z-2607-2024
Product summary
- Event
- Event 94852
- Status
- Ongoing
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2607-2024
Official wording
Reason: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Code information: UDI/DI 15021312006230, Product Code/List Number/Item Code 67N040, Serial Numbers: 3877658, 3901313, 3923737, 3936563, 3942521, 3965334, 4016051, 4331550, 4334880, 4352757, 4362870, 4369535, 4380068
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect