Device recall
Z-1294-2015: LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is…
FDA device recall · Class III · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-1294-2015 |
|---|---|
| Recall event | 70698 |
| Product | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252 |
| Product code | DWQ |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 21, 2015 |
| 510(k) numbers | K041453 |
| FEI number | 1220948 |
At a glance
- 1–9 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