INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhala
FDA device recall Z-0575-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- INO Therapeutics (dba Ikaria)
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- MRN
- Quantity affected
- 9
- Distribution
- US Distribution in states of: VA and PA only.
- Date initiated
- 2014-10-17
- Date posted
- 2014-12-12
- Date terminated
- 2015-04-16
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INOMAX DSIR (DELIVERY SYSTEM) (K131686) | Ino Therapeutics/Ikaria | 2013-11-29 |