Device recall
Z-2176-2010: Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton…
FDA device recall · Class I · Ikaria Holdings
Key facts
| Recall number (Z-number) | Z-2176-2010 |
|---|---|
| Recall event | 56290 |
| Product | Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. The INOMAX DS 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… |
| Product code | MRN |
| Recalling firm | Ikaria Holdings |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 27, 2011 |
| 510(k) numbers | K061901 |
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