Device recall
Z-1745-2022: INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation)…
FDA device recall · Class II · Mallinckrodt, LLC.
Key facts
| Recall number (Z-number) | Z-1745-2022 |
|---|---|
| Recall event | 90723 |
| Product | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007 |
| Product code | MRN |
| Recalling firm | Mallinckrodt, LLC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K061901 |
| FEI number | 3014074925 |
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