FDA Device recall Z-2593-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product…
- FDA Device
- Class I
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class I recall of PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product… by Smiths Medical Asd, citing 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 defe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2593-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-29 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
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
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.
Identifiers
| code_info | UDI/DI 15021312516678, Product Code/List Number/Item Code 60NFPS25, Lot Numbers: 3853440, 3874312, 3891526, 3904670, 3…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2593-2024%22
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