CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report

Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system recalled

INO Therapeutics ( is recalling Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system, distributed in 18 states. The recall was initiated on 21 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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.

Quantity recalled45

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1076-2017
FDA event ID: 75878
Recalling firm: INO Therapeutics (, Madison, WI
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2016
FDA classified: 23 Jan 2017
Reported: 1 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

21 Nov 2016	Recall initiated by company
23 Jan 2017	Classified by FDA	+63 days
1 Feb 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

California Colorado District of Columbia Florida Georgia Hawaii Iowa Illinois Indiana Michigan Minnesota North Carolina New Jersey New Mexico New York Ohio Pennsylvania Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from INO Therapeutics (

All 4

Reported	Class	Recall	Company	Reason	Where
11 Mar 2015Device	CLASS II	Ikaria, INOmax DSIR (Delivery System) recalled by INO Therapeutics (	INO Therapeutics (	Device Malfunction	Nationwide
17 Dec 2014Device	CLASS II	Inomax Dsir Nitric Oxide delivery system recalled by INO Therapeutics (	INO Therapeutics (	Device Malfunction	PA, VA
14 May 2014Device	CLASS II	INOmax DSIR recalled by INO Therapeutics (	INO Therapeutics (	Device Malfunction	Nationwide

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