FDA Device recall Z-2946-2020
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up…
- FDA Device
- Class II
- terminated
- Published 2020-09-16
On 2020-09-16 the FDA classified a Class II recall of Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up… by Smiths Medical Asd, citing label has the incorrect size for the tracheotomy tube.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2946-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-28 |
| Published | 2020-09-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smiths Medical Asd |
| Distribution | CT |
Product
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Reason
Label has the incorrect size for the tracheotomy tube.
Identifiers
| code_info | Lot# 3952216 |
|---|
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-2946-2020%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.