Device recall
Z-2745-2011: HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy…
FDA device recall · Class II · Barrx Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2745-2011 |
|---|---|
| Recall event | 58908 |
| Product | HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal… |
| Product code | GEI |
| Recalling firm | Barrx Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2011 |
| 510(k) numbers | K101111 |
| FEI number | 3004904811 |
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