Recall Z-2701-2014 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox 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, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mi
| 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 | 635 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 |