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.
FDA Recall Z-1076-2017 · Posted None
Advertisement
Recalling FirmINO Therapeutics (dba Ikaria)
Recall StatusTerminated
Product CodeMRN
Date Initiated2016-11-21
Date Terminated2017-12-20
Product Quantity45
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.
Firm 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).
Root Cause
Equipment maintenance
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement