Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm, Inc. is recalling 865 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 involves a medical device used for breathing gases where a defect (water leakage) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vapotherm, Inc. is recalling 865 units of the Precision Flow Disposable Patient Circuit (PFHDPC-Low). The recall is due to a defect that allows water to leak into the center gas lumen of the device. The product is intended for use with the Heliox Precision Flow system to add warm moisture to breathing gases for neonates, infants, pediatric, and adult patients in hospital, sub-acute, and home settings.
The affected lot numbers are 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers apply regardless of the prefix preceding them (HF, HFE, HFH, HFN, LF, LFE, LFH, or LFN). The products 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.
Healthcare facilities and consumers should stop using the affected devices and contact Vapotherm, Inc. for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. 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 patie
- Manufacturer
- Vapotherm, Inc.
- Affected units
- 865
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
Same manufacturer · Vapotherm, Inc.
See all →- HighVapotherm Precision Flow Patient Circuits Recalled for Water Leakage
FDA (Devices) · 2014-10-01
- SevereVapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks
FDA (Devices) · 2014-10-01
- HighVapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage
FDA (Devices) · 2014-10-01
- HighVapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
FDA (Devices) · 2014-10-01
- HighVapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
FDA (Devices) · 2014-10-01
Same hazard · water leakage
See all →- HighGetinge CM320 Washer Disinfector Recalled for Hose Deformation Risk
FDA (Devices) · 2021-02-24
- SevereAurobindo Recalls Gabapentin Capsules Due to Manufacturing Water Leakage
FDA (Drugs) · 2020-04-22
- ModerateAurobindo Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2020-04-22
- ModerateAurobindo Recalls Oxycodone and Acetaminophen Tablets Due to Water Leakage
FDA (Drugs) · 2020-04-22
- ModerateAurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage
FDA (Drugs) · 2020-04-22