FDA Device recall Z-1076-2017
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system by Ino Therapeutics Dba Ikaria, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1076-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-21 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ino Therapeutics Dba Ikaria |
| Distribution | CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, TX |
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
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.
Identifiers
| code_info | Serial Numbers: DS20070030, DS20070043, DS20070094, DS20070268, DS20090096, DS20090458, DS20090484, DS20090539, DS2009…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.