FDA Device recall Z-2114-2018
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of Bivona¿ Tracheostomy Tube Tracheostomy Tubes by Smiths Medical Asd, citing carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2114-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-02 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | CA, FL, GA, ID, NJ, NM, OH, VA |
Product
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Reason
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Identifiers
| code_info | Part No. (Lot No.): CMZ3241N (DS009716), ST16EN80NSC194N (DS009794), SU15AN70NSC153N (DS009577), FT17IN60NGC114N (DS0…Part No. (Lot No.): CMZ3241N (DS009716), ST16EN80NSC194N (DS009794), SU15AN70NSC153N (DS009577), FT17IN60NGC114N (DS009894), CMZ3331N (DS009761), XU17GS50NSF046N (DS009609), FT17IN60NGC114N (DS009861), AA16ES70NSC110N (DS009586), FT17IN70NSC111N (DS009856), FT16IN60NGC053N (DS009540), FU15AN55NSA076N (DS009464), AT17IS60NGC105N (DS009811) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2114-2018%22
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