Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm, Inc. is recalling 1,005 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, and the hazard involves a medical device used for breathing support where water leakage into the gas lumen poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Vapotherm, Inc. is recalling 1,005 units of Vapotherm Precision Flow Disposable Patient Circuits (model PF-E-DPC-High). The recall is due to a defect that allows water to leak into the center gas lumen of the device.
The affected product is intended for use with the 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 product was 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 circuits and contact Vapotherm, Inc. for instructions on return or replacement.
The recalled product
- Product
- Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the 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 patients i
- Manufacturer
- Vapotherm, Inc.
- Affected units
- 1,005
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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