INO Therapeutics (dba Ikaria)
INO Therapeutics (dba Ikaria) appears in FDA public data with 4 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1076-2017, Class II) was initiated on November 21, 2016.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1076-2017 | Class II | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitri | November 21, 2016 |
| Z-1223-2015 | Class II | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with vent | January 14, 2015 |
| Z-0575-2015 | Class II | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nit | October 17, 2014 |
| Z-1528-2014 | Class II | INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS | March 27, 2014 |