Recall Z-0575-2015 ยท MRN Apparatus, Nitric Oxide Delivery
INO Therapeutics (dba Ikaria)
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
| Date | Dec 12, 2014 (initiated Oct 17, 2014) |
| Status | Terminated |
| Reason | An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board. |
| Root cause | Process change control |
| Action | Ikaria contacted consignees by phone beginning 10/17/2014. A follow-up letter was sent to customers beginning 10/22/2014. The letter described the issue, requested that affected devices not be used and to return to Ikaria. Customers with questions can contact Ikaria Customer Care at 1-877-566-9466. |
| Quantity | 9 |
| Distribution | US Distribution in states of: VA and PA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) Ino Therapeutics/Ikaria, Nov 29, 2013 |