Device 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.
Z-2699-2014
Product summary
- Firm
- Vapotherm, Inc.
- Event
- Event 69116
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22828 units
- Official record key
device-enforcement:Z-2699-2014
Official wording
Reason: Disposable Patient Circuit that allows water to leak into the center gas lumen
Code information: Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).
Distribution pattern: 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.
Derived failure modes
-
Unknown
Disposable Patient Circuit that allows water to leak into the center gas lumen