Device recall
Z-0192-2009: Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters…
FDA device recall · Class II · Barrx Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0192-2009 |
|---|---|
| Recall event | 49515 |
| Product | Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B. |
| Product code | GEI |
| Recalling firm | Barrx Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| FEI number | 3004904811 |
At a glance
- None 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