FDA Device recall Z-1465-2017
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035 by Smiths Medical Asd, citing smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1465-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-09 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | CA, CO, CT, FL, GA, LA, MA, MD, MI, MN, MO, NC, NE, OK, PA, SC, TN, TX, WA, WI |
Product
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Reason
Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.
Identifiers
| code_info | 3272963 |
|---|
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-1465-2017%22
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