Recall Z-2176-2010 ยท MRN Apparatus, Nitric Oxide Delivery
Ikaria Holdings
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 oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a speciall
| Date | Aug 13, 2010 (initiated Jul 21, 2010) |
| Status | Terminated |
| Reason | The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOMAX therapy may cause: -worsening of systemic oxygenation indices (i.e., hypoxemia, especially manifested as decreased arterial oxygenation saturation). -hypotension, and/or -increase in pulm |
| Root cause | Component design/selection |
| Action | Ikaria sent an Urgent Medical Device Recall letter to customers dated July 21, 2010. This letter is also posted on the Inomax webpage. The letter described the issue, how to recognize it, what to do in the event of a suspected leak, and recommended maintaining back-up cylinders and depressurization of the regulator when not in use. The replacement plan for all INOMAX DS drug-delivery systems was described. Customers can contact Ikaria Customer Care at 1-877-566-9466. |
| Quantity | 2507 |
| Distribution | Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 Ino Therapeutics, Dec 14, 2006 |