Device recall
Z-2528-2018: Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure…
FDA device recall · Class II · Medela Inc
Key facts
| Recall number (Z-number) | Z-2528-2018 |
|---|---|
| Recall event | 80078 |
| Product | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model… |
| Product code | OMP |
| Recalling firm | Medela Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2018 |
| 510(k) numbers | K161128 |
| FEI number | 1419937 |
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