Vapotherm, Inc. Recall: Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High.
Vapotherm, Inc. Recall: Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Vapotherm, Inc.; Product: Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax
| Recalling firm | Vapotherm, Inc. |
|---|---|
| Product | Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, |
| Reason for recall | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy. |
| Recall initiated | 20140813 |
| Recall number | Z-2702-2014 |
| Category | device |
| State | NH |
| Country | United States |
$29/mo
Try RecallGuard →