Vapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage
Vapotherm, Inc. is recalling 207 units of Precision Flow Disposable Patient Circuits because water may 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 potential water leakage into a medical device used for gas delivery, which poses a risk of harm to patients, but the source text does not report specific injuries or illnesses.
Plain-English summary
Vapotherm, Inc. is recalling 207 units of Vapotherm Precision Flow Disposable Patient Circuits (PF-NODPC-Low). These devices are used with the Precision Flow system and Ikaria INOmax DSIR System to administer nitric oxide non-invasively via high flow nasal cannula.
The recall was initiated because water may leak into the center gas lumen of the patient circuit. The affected lot numbers range from 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These lot numbers apply regardless of the prefix preceding them (i.e. 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. Clinicians and facilities should stop using the affected devices and contact Vapotherm, Inc. for further instructions.
The recalled product
- Product
- Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Thera
- Manufacturer
- Vapotherm, Inc.
- Affected units
- 207
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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See all →- HighVapotherm Precision Flow Patient Circuits Recalled for Water Leakage
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- HighVapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
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- HighVapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
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