FDA-Device2014-10-01Class II

Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system

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
360 units
Manufactured in
22 Industrial Dr Ste 1, N/A, Exeter, NH, United States
Products
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2704-2014

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