Device recall
Z-0338-06: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110…
FDA device recall · Class III · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0338-06 |
|---|---|
| Recall event | 32916 |
| Product | Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70. |
| Product code | BTO |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 6, 2007 |
| 510(k) numbers | K922665 |
| FEI number | 1824231 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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