CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report
Precision Flow,Disposable Patient Circuit Pf-nodpc-Low recalled
Vapotherm is recalling Vapotherm Precision Flow,Disposable Patient Circuit Pf-nodpc-Low, distributed nationwide in the US. The recall was initiated on 13 Aug 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2706-2014
- FDA event ID
- 69116
- Recalling firm
- Vapotherm, Exeter, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2014
- FDA classified
- 25 Sep 2014
- Reported
- 1 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 13 Aug 2014 | Recall initiated by company | |
| 25 Sep 2014 | Classified by FDA | +43 days |
| 1 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Water may leak into the center gas lumen of the Patient Circuit
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.
Questions about this recall
Is Precision Flow,Disposable Patient Circuit Pf-nodpc-Low recalled?
Yes. Vapotherm recalled Precision Flow,Disposable Patient Circuit Pf-nodpc-Low on 13 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-2706-2014.
Why was it recalled?
Water may leak into the center gas lumen of the Patient Circuit
Which lots are affected?
Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vapotherm
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Low Flow Disposable Patient Circuit recalled by Vapotherm | Vapotherm | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Precision Flow,Disposable Patient Circuit Pfh-dpc-High recalled | Vapotherm | Packaging Defects | Nationwide |
| Device | CLASS II | Precision Flow,Disposable Patient Circuit Pf-e-dpc-Low recalled | Vapotherm | Packaging Defects | Nationwide |
| Device | CLASS II | Precision Flow,Disposable Patient Circuit Pf-dpc-Low recalled | Vapotherm | Packaging Defects | Nationwide |
| Device | CLASS II | Precision Flow,Disposable Patient Circuit Pfhdpc-Low recalled | Vapotherm | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |