Z-1076-2017Class II

Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for...

Name: Z-1076-2017 Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for...
Creator: INO Therapeutics (dba Ikaria)
Published: 2016-11-21
License: https://open.fda.gov/license/

Mallinckrodt Manufacturing LLC / initiated 2016-11-21 / Terminated / root cause: manufacturing process

FDA source

INO Therapeutics (dba Ikaria) began a recall of Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel... on 2016-11-21. FDA classified it as Class II and gives the reason as "Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device". 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-1076-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2017-01-23
Terminated: 2017-12-20
Recalling firm: Mallinckrodt Manufacturing LLC
Product: Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
Product code: MRN Apparatus, Nitric Oxide Delivery
Reason for recall: Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Recall letter was sent to customers in a e-mail beginning November 21, 2016 with a had copy sent via FedEx overnight with signature receipt beginning December 5, 2016. Devices will be picked up and replaced by Mallinckrodt. Questions can be directed to 1-877-KNOW-INO (1-877-566-9466).
Quantity in commerce: 45
Distribution: US Distribution to the states of : CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, and TX
Product codes and lots: Serial Numbers: DS20070030, DS20070043, DS20070094, DS20070268, DS20090096, DS20090458, DS20090484, DS20090539, DS20090620, DS20090645, DS20100071, DS20100118, DS20100216, DS20100266, DS20100268, DS20100330, DS20100439, DS20100496, DS20100604, DS20100675, DS20100744, DS20100762, DS20100950, DS20101199, DS20101337, DS20101359, DS20101369, DS20101406, DS20101443, DS20101524, DS20110242, DS20110480, DS20110577, DS20110849, DS20110868, DS20110912, DS20110915, DS20110972, DS20110976, DS20110990, DS20120008, DS20120161, DS20120266, DS20120281, DS20120370.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1076-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1076-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23

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)