Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system — Class II medical device recall Z-1076-2017
Terminated recall by INO Therapeutics (dba Ikaria), reported 2017-02-01, distributed in CA, CO, DC, FL, GA, HI, IA, IL…. Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which
| Recall number | Z-1076-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | INO Therapeutics (dba Ikaria), Madison, WI, United States |
| Recall initiated | 2016-11-21 |
| Classified | 2017-01-23 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-12-20 |
| Distributed | CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, TX |
| Quantity | 45 |
| 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 and 20 more |
| Model numbers | 10007 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1076-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.