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Recall Observatory FDA recall evidence

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

August 13, 2014

Class II

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

    reason.no_named_rule · v1.0.0

    Disposable Patient Circuit that allows water to leak into the center gas lumen