Device recall
Z-1146-2018: ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The…
FDA device recall · Class II · Vascular Insights, LLC
Key facts
| Recall number (Z-number) | Z-1146-2018 |
|---|---|
| Recall event | 79324 |
| Product | ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature. |
| Product code | KRA |
| Recalling firm | Vascular Insights, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 18, 2018 |
| 510(k) numbers | K071468 |
| FEI number | 3005831739 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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