FDA Device recall Z-0726-2021
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
- FDA Device
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 by Smiths Medical Asd, citing A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0726-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-15 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Reason
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Identifiers
| code_info | Lot Number 3991195 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0726-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.