FDAFDA · Food and drugs·Recall number Z-2704-2014
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
Published October 1, 2014 · Recall initiated: August 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Disposable Patient Circuit that allows water to leak into the center gas lumen
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vapotherm, Inc.
- Distributor
- 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.
- Lot
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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