Device recall
Z-3239-2017: IVEA Product Part Number 16100 Model 500A
FDA device recall · Class II · Firefly Medical, Inc.
Key facts
| Recall number (Z-number) | Z-3239-2017 |
|---|---|
| Recall event | 78019 |
| Product | IVEA Product Part Number 16100 Model 500A |
| Product code | FOX |
| Recalling firm | Firefly Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2019 |
| FEI number | 3011390406 |
At a glance
- None 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