Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm, Inc. is recalling 635 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device used for breathing gases where water leakage into the gas lumen poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Vapotherm, Inc. is recalling 635 units of Vapotherm Precision Flow Disposable Patient Circuits (model PFH-DPC-High). The recall is due to a defect that allows water to leak into the center gas lumen of the device.
The affected devices are intended for use with the Heliox Precision Flow system to add warm moisture to breathing gases for neonate, infant, pediatric, and adult patients in hospital, sub-acute, and home settings. The recall covers lot numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These lot numbers apply regardless of the prefix (HF, HFE, HFH, HFN, LF, LFE, LFH, or LFN).
The affected units were distributed nationwide in the United States and internationally to Canada, France, Switzerland, Korea, Sweden, Germany, Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, Kuwait, and Italy. Users should stop using the affected devices and contact Vapotherm, Inc. for instructions on return or replacement.
The recalled product
- Product
- Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox 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 pati
- Manufacturer
- Vapotherm, Inc.
- Affected units
- 635
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers 1402021 through 1406010
- HFE
- HFH
- HFN
- LF
- LFE
- LFH or LFN).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Vapotherm, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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