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Terminated

Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

FDA Recall Z-2176-2010 · Posted 2010-08-13

Recalling FirmIkaria Holdings
Recall StatusTerminated
Product CodeMRN
Date Initiated2010-07-21
Date Terminated2011-12-27
Product Quantity2507

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

Firm Action

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

Distribution Pattern

Worldwide Distribution to include: US Nationwide and Countries of Canada and Malaysia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061901INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003Ino Therapeutics · 2006-12-14

Official Source

View FDA Recall →

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

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