Device product
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
Z-2704-2014
Product summary
- Firm
- Vapotherm, Inc.
- Event
- Event 69116
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 units
- Official record key
device-enforcement:Z-2704-2014
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