Device recall
Z-2089-2014: Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular…
FDA device recall · Class II · Perouse Medical
Key facts
| Recall number (Z-number) | Z-2089-2014 |
|---|---|
| Recall event | 68795 |
| Product | Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. |
| Product code | MAV |
| Recalling firm | Perouse Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2014 |
| 510(k) numbers | K082755 |
| FEI number | 3004160911 |
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