Device recall
Z-2126-2014: FlowCOUPLER. An implantable device that is used to detect blood flow in vessels…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-2126-2014 |
|---|---|
| Recall event | 68789 |
| Product | FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency… |
| Product code | DPW |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2015 |
| 510(k) numbers | K132727 |
| FEI number | 3000121413 |
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