Z-0575-2015Class II

INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide...

Name: Z-0575-2015 INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide...
Creator: INO Therapeutics (dba Ikaria)
Published: 2014-10-17
License: https://open.fda.gov/license/

Mallinckrodt Manufacturing LLC / initiated 2014-10-17 / Terminated / root cause: manufacturing process

FDA source

INO Therapeutics (dba Ikaria) began a recall of INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides... on 2014-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0575-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Posted: 2014-12-12
Terminated: 2015-04-16
Recalling firm: Mallinckrodt Manufacturing LLC
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.
Product code: MRN Apparatus, Nitric Oxide Delivery
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0575-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0575-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09

Product code MRN

K131686Class IIInomax Dsir (Delivery System)Ino Therapeutics/Ikaria / cleared 2013-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)