Recall Z-0583-2012 ยท MRN Apparatus, Nitric Oxide Delivery
Ino Therapeutics
INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracki
| Date | Jan 11, 2012 (initiated Nov 30, 2010) |
| Status | Terminated |
| Reason | Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10. |
| Root cause | Nonconforming Material/Component |
| Action | Ikaria sent a "RECALL- CUSTOMER PRODUCT REMEDIATION" notice dated December 22, 2011 to all affected customers. The letter describes the product, problem, actions taken by the firm. No action was required by customers. The notice served as correspondence to inform customers of the issue. Customers may direct their questions to Ikaria Customer Care at 1-877-566-9466. |
| Quantity | 2446 |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of MALAYSIA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 Ino Therapeutics, Dec 14, 2006 |