Device recall
Z-1223-2015: Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system…
FDA device recall · Class II · INO Therapeutics (dba Ikaria)
Key facts
| Recall number (Z-number) | Z-1223-2015 |
|---|---|
| Recall event | 70395 |
| Product | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. |
| Product code | MRN |
| Recalling firm | INO Therapeutics (dba Ikaria) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2015 |
| 510(k) numbers | K093922 |
| FEI number | 3004531588 |
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