Recall Z-1076-2017 ยท MRN Apparatus, Nitric Oxide Delivery
INO Therapeutics (dba Ikaria)
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 sepa
| Date | Nov 21, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Equipment maintenance |
| 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). |
| Quantity | 45 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) Ino Therapeutics/Ikaria, Nov 29, 2013 |