Device recall
Z-2733-2018: Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage…
FDA device recall · Class II · INO therapeutics LLC/dba ikaria
Key facts
| Recall number (Z-number) | Z-2733-2018 |
|---|---|
| Recall event | 80555 |
| Product | Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product… |
| Product code | MRN |
| Recalling firm | INO therapeutics LLC/dba ikaria |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2020 |
| 510(k) numbers | K131686 |
| FEI number | 2350054 |
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