Recall Z-2702-2014 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Vapotherm, Inc.
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 Precisio
| Date | Sep 25, 2014 (initiated Aug 13, 2014) |
| Status | Terminated |
| Reason | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Root cause | Process control |
| Action | Vapotherm issued an Initial Notification on August 13, 2014. The letter was updated on August 20, 2014 to include two additional lots. The recall letter notified users that this defect is easily detectable during normal use and the probability of serious injury or death is remote. The letter was sent to raise awareness of the recent increase in incidence rate of this issue and reminded users of the requirement in the operating manual that requires that the cannula be connected to the patient only after the set temperature is reached. The letter also advised patient care personnel not to use, o |
| Quantity | 387 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072845 | PRECISION FLOW Vapotherm, Inc., Jul 17, 2008 |