Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. The INOMAX DS Delivery Sy
FDA device recall Z-2176-2010 · posted 2010-08-13 · Terminated
Recall details
- Recalling firm
- Ikaria Holdings
- Reason for recall
- The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOMAX therapy may cause: -worsening of systemic oxygenation indices (i.e., hypoxemia, especially manifested as decreased arterial oxygenation saturation). -hypotension, and/or -increase in pulm
- Action taken
- Ikaria sent an Urgent Medical Device Recall letter to customers dated July 21, 2010. This letter is also posted on the Inomax webpage. The letter described the issue, how to recognize it, what to do in the event of a suspected leak, and recommended maintaining back-up cylinders and depressurization of the regulator when not in use. The replacement plan for all INOMAX DS drug-delivery systems was described. Customers can contact Ikaria Customer Care at 1-877-566-9466.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MRN
- Quantity affected
- 2507
- Distribution
- Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia
- Date initiated
- 2010-07-21
- Date posted
- 2010-08-13
- Date terminated
- 2011-12-27
- Location
- Clinton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K061901) | Ino Therapeutics | 2006-12-14 |