Agency classClass IIOur severity:High FDA (Devices)·Z-2699-2014·Announced 2014-10-01

Vapotherm Precision Flow Patient Circuits Recalled for Water Leakage

Vapotherm, Inc. is recalling 22,828 Precision Flow Disposable Patient Circuits because they may allow water to leak into the gas lumen.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 defect (water leakage into the gas lumen) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Vapotherm, Inc. is recalling 22,828 units of Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. The recall is due to a defect where the device allows water to leak into the center gas lumen.

The affected products are intended to add warm moisture to breathing gases for neonates, infants, 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 lots 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 providers and consumers should stop using the affected patient circuits and contact Vapotherm, Inc. for instructions on return or replacement.

The recalled product

Product: Vapotherm Precision Flow, Disposable Patient Circuit PF-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…
Manufacturer: Vapotherm, Inc.
Category: Medical Device — Respiratory Therapy
Hazard: water-leakage
device-defect
Affected units: 22,828

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 →

Same manufacturer · Vapotherm, Inc.

See all →

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Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks
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High
Vapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage
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High
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
FDA (Devices) · 2014-10-01
High
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
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Same hazard · water leakage