Recall Z-1223-2015 ยท MRN Apparatus, Nitric Oxide Delivery
INO Therapeutics (dba Ikaria)
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
| Date | Feb 27, 2015 (initiated Jan 14, 2015) |
| Status | Terminated |
| Reason | Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted. |
| Root cause | Process change control |
| Action | Consignees were sent on 1/14/2015 an Ikaria "Urgent Field Correction Action" letter dated January 14, 2015. The letter described the problem and the product involved in the recall. The letter provided a number of recommendations to the consginees in regard to use and return of the product. For questions or adverse events they can contact Ikaria Customer Care at 1-877-KNOW-INO (1-877-566-9466) 24 hours a day, 7 days a week. |
| Quantity | 45 units |
| Distribution | Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093922 | INOMAX DS Ino Therapeutics, Apr 15, 2010 |