Device product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
Z-2593-2024
Product summary
- Event
- Event 94852
- Status
- Ongoing
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2593-2024
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 15021312516678, Product Code/List Number/Item Code 60NFPS25, Lot Numbers: 3853440, 3874312, 3891526, 3904670, 3923733, 3946227, 3952384, 3965919, 3991145, 4015537, 4035730, 4095917, 4119108, 4134019, 4156630, 4173731, 4179354, 4327881, 4334986, 4351236, 4374430, 4388157, 4395780,
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing defect