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Vapotherm, Inc. recalls Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria
Recalled October 1, 2014 · FDA recall Z-2706-2014 · Vapotherm
Hazard
Water may leak into the center gas lumen of the Patient Circuit · FDA Class II
Units
207 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
Water may leak into the center gas lumen of the Patient Circuit
Product
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. 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 Precision Flow system
Manufacturer(s)
Vapotherm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →