Device recall
Z-0721-05: Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060…
FDA device recall · Class II · Nellcor Puritan Bennett
Key facts
| Recall number (Z-number) | Z-0721-05 |
|---|---|
| Recall event | 31273 |
| Product | Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed… |
| Product code | JDH |
| Recalling firm | Nellcor Puritan Bennett |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2006 |
| 510(k) numbers | K030787 |
| FEI number | 2936999 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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