INOmax DSIR Plus Delivery System Recalled for Inaccurate Valve Calibration
INO Therapeutics is recalling 45 INOmax DSIR Plus delivery systems because an out-of-tolerance manometer may cause inaccurate valve calibration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to inaccurate delivery of a potent medication (nitric oxide), representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
INO Therapeutics (dba Ikaria) is recalling 45 units of the Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system, Model 10007. The device is used to deliver INOMAX (nitric oxide for inhalation) and features a dual-channel design for delivery and monitoring.
The recall was initiated after the manufacturer discovered that some devices may have been manufactured with an out-of-tolerance manometer. This defect can result in an inaccurate proportional valve calibration table within the affected device.
The affected units were distributed in the United States to the states of California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, and Texas. Specific serial numbers for the 45 affected units are listed in the official recall documentation.
The recalled product
- 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…
- Manufacturer
- INO Therapeutics (dba Ikaria)
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: DS20070030
- DS20070043
- DS20070094
- DS20070268
- DS20090096
- DS20090458
- DS20090484
- DS20090539
- DS20090620
- DS20090645
- DS20100071
- DS20100118
- DS20100216
- DS20100266
- DS20100268
- DS20100330
- DS20100439
- DS20100496
- DS20100604
- DS20100675
Distribution
Related recalls
Same manufacturer · INO Therapeutics (dba Ikaria)
See all →- HighIkaria INOmax DSIR Nitric Oxide Delivery System Recalled for Alarm Defect
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Similar recalls
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FDA (Devices) · 2015-03-11
- HighINOmax DSIR Nitric Oxide System Recalled for Monitoring Error
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- HighINOmax DSIR Delivery System incompatible with upgraded Leoni Plus ventilator
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