Device recall
Z-1076-2017: Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007…
FDA device recall · Class II · INO Therapeutics (dba Ikaria)
Key facts
| Recall number (Z-number) | Z-1076-2017 |
|---|---|
| Recall event | 75878 |
| Product | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure… |
| Product code | MRN |
| Recalling firm | INO Therapeutics (dba Ikaria) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 20, 2017 |
| 510(k) numbers | K131686 |
| 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