Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
FDA device recall Z-1223-2015 · posted 2015-02-27 · Terminated
Recall details
- Recalling firm
- INO Therapeutics (dba Ikaria)
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- MRN
- Quantity affected
- 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.
- Date initiated
- 2015-01-14
- Date posted
- 2015-02-27
- Date terminated
- 2015-04-15
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INOMAX DS (K093922) | Ino Therapeutics | 2010-04-15 |