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U.S. Department of Health and Human Services

Class 2 Device Recall INOmax DSIR

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  Class 2 Device Recall INOmax DSIR see related information
Date Initiated by Firm October 17, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on April 16, 2015
Recall Number Z-0575-2015
Recall Event ID 69635
510(K)Number K131686  
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
Product INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
Code Information Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.
Recalling Firm/
INO Therapeutics (dba Ikaria)
2902 Dairy Dr
Madison WI 53718-3809
For Additional Information Contact Ikaria Customer Care
Manufacturer 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.
FDA Determined
Cause 2
Process change control
Action 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.
Quantity in Commerce 9
Distribution US Distribution in states of: VA and PA only.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRN and Original Applicant = INO THERAPEUTICS/IKARIA