Device recall
Z-1399-2017: Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker…
FDA device recall · Class II · Parker Medical
Key facts
| Recall number (Z-number) | Z-1399-2017 |
|---|---|
| Recall event | 76299 |
| Product | Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for… |
| Product code | CBI |
| Recalling firm | Parker Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2017 |
| 510(k) numbers | K092886 |
| FEI number | 3002986772 |
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