Company: INO Therapeutics (dba Ikaria).
Date of Enforcement Report 12/17/2014
Class lI:
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.
Recall Number Z-0575-2015
REASON
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..
RECALLING FIRM/MANUFACTURER
INO Therapeutics (dba Ikaria), Madison WI 10/17/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9
DISTRIBUTION
US Distribution in states of: VA and PA only.
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