Recall record at a glance
| Official record | Z-0575-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | INO Therapeutics (dba Ikaria) |
| Report date | Dec 17, 2014 |
| Recall initiation date | Oct 17, 2014 |
| Quantity | 9 |
| Location | Madison, WI, United States |
Official product description
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
Why the product was recalled
An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.
Distribution information
US Distribution in states of: VA and PA only.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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