Device product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Z-2590-2024
Product summary
- Event
- Event 94852
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3138 units
- Official record key
device-enforcement:Z-2590-2024
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: a) UDI/DI 15021312005684, Product Code/List Number/Item Code 60N025, Lot Numbers: 3853476, 3868313, 3911441, 3952404, 3965318, 3991202, 4006287, 4006294, 4097838, 4125826, 4148013, 4185431, 4206833, 4221354, 4238779, 4331627, 4345039, 4348774, 4383653, 4400691
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect