Device recall
Z-0021-2026: NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number…
FDA device recall · Class II · Northeast Scientific Inc.
Key facts
| Recall number (Z-number) | Z-0021-2026 |
|---|---|
| Recall event | 97524 |
| Product | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the… |
| Product code | QTF |
| Recalling firm | Northeast Scientific Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3005467144 |
At a glance
- None 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