Device recall
Z-1891-2017: DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030…
FDA device recall · Class II · PEROUSE MEDICAL
Key facts
| Recall number (Z-number) | Z-1891-2017 |
|---|---|
| Recall event | 77100 |
| Product | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND |
| Product code | MAV |
| Recalling firm | PEROUSE MEDICAL |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2021 |
| 510(k) numbers | K042449 |
| FEI number | 3006942524 |
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