INOmax DS (Delivery System) Model 10003 & 10007. 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-0583-2012 · Posted 2012-01-11
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Recalling FirmIno Therapeutics
Recall StatusTerminated
Product CodeMRN
Date Initiated2010-11-30
Date Terminated2012-05-29
Product Quantity2446
Reason for Recall
Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.
Firm Action
Ikaria sent a "RECALL- CUSTOMER PRODUCT REMEDIATION" notice dated December 22, 2011 to all affected customers. The letter describes the product, problem, actions taken by the firm. No action was required by customers. The notice served as correspondence to inform customers of the issue. Customers may direct their questions to Ikaria Customer Care at 1-877-566-9466.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the country of MALAYSIA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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