Device recall
Z-1019-2022: Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-1019-2022 |
|---|---|
| Recall event | 89897 |
| Product | Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. |
| Product code | DXC |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2026 |
| 510(k) numbers | K981624 |
| FEI number | 1417572 |
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