Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks
Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where the defect could lead to adverse health consequences.
Plain-English summary
Vapotherm, Inc. is recalling 387 units of the Precision Flow Disposable Patient Circuit (PFNODPC-High). The recall covers lot numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These circuits are used with the Precision Flow system and Ikaria INOmax DSIR System to administer nitric oxide non-invasively via high flow nasal cannula to neonates, infants, pediatric, and adult patients.
The recall was initiated because the disposable patient circuit may allow water to leak into the center gas lumen. 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.
Healthcare facilities and consumers should stop using the affected devices and contact Vapotherm, Inc. for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. 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…
- Manufacturer
- Vapotherm, Inc.
- Hazard
- Affected units
- 387
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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