FDA-Device2014-10-01Class II
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. 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 mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer.
Vapotherm, Inc.
Hazard
Disposable Patient Circuit that allows water to leak into the center gas lumen
Sold states
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.
Affected count
865 units
Manufactured in
22 Industrial Dr Ste 1, N/A, Exeter, NH, United States
Products
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. 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 mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2705-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief