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Terminated

Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

FDA Recall Z-1223-2015 · Posted 2015-02-27

Recalling FirmINO Therapeutics (dba Ikaria)
Recall StatusTerminated
Product CodeMRN
Date Initiated2015-01-14
Date Terminated2015-04-15
Product Quantity45 units

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.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093922INOMAX DSIno Therapeutics · 2010-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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