Device recall
Z-0657-2012: Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped…
FDA device recall · Class I · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0657-2012 |
|---|---|
| Recall event | 60449 |
| Product | Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange). |
| Product code | BTO |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 17, 2014 |
| 510(k) numbers | K912469 |
| FEI number | 1824231 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database