Home / Recalls / Medical Devices
Vapotherm, Inc. recalls Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision F
Recalled October 1, 2014 · FDA recall Z-2699-2014 · Vapotherm
Hazard
Disposable Patient Circuit that allows water to leak into the center gas lumen · FDA Class II
Units
22828 units
Sold at
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.
Description
Disposable Patient Circuit that allows water to leak into the center gas lumen
Product
Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with 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, 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.
Manufacturer(s)
Vapotherm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →