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Recall Observatory FDA recall evidence

Device 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

Z-2706-2014

August 13, 2014

Class II

Product summary

Firm
Vapotherm, Inc.
Event
Event 69116
Status
Terminated
Classification
Class II
Quantity
207 units
Official record key
device-enforcement:Z-2706-2014

Official wording

Reason: Water may leak into the center gas lumen of the Patient Circuit

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

    Water may leak into the center gas lumen of the Patient Circuit