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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 67947
Product Type Devices
Status Ongoing
Recalling Firm INO Therapeutics (dba Ikaria)
City Madison
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including DC and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306. Class II An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater than 200 ppm/25 ppm respectively over a 10 second period. 22 Z-1528-2014