Device recall
Z-2334-2021: NES Reprocessed Visions PV.035 IVUS Catheter, Sterile. For use in the…
FDA device recall · Class II · Northeast Scientific Inc.
Key facts
| Recall number (Z-number) | Z-2334-2021 |
|---|---|
| Recall event | 88345 |
| Product | NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901 |
| Product code | OWQ |
| Recalling firm | Northeast Scientific Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2022 |
| FEI number | 3005467144 |
At a glance
- None 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