Device recall
Z-0008-2008: CVI OZ Palm Injector, used to perfuse contrast media into vessels for…
FDA device recall · Class II · Lemaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-0008-2008 |
|---|---|
| Recall event | 38894 |
| Product | CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) |
| Product code | DXT |
| Recalling firm | Lemaitre Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2008 |
| 510(k) numbers | K973334 |
| FEI number | 1220948 |
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