Z-2704-2014Class II

Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible...

Name: Z-2704-2014 Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible...
Creator: Vapotherm, Inc.
Published: 2014-08-13
License: https://open.fda.gov/license/

Vapotherm Inc. / initiated 2014-08-13 / Terminated / root cause: manufacturing process

FDA source

Vapotherm, Inc. began a recall of Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system on 2014-08-13. FDA classified it as Class II and gives the reason as "Disposable Patient Circuit that allows water to leak into the center gas lumen". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2704-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-13
Posted: 2014-09-25
Terminated: 2015-10-02
Recalling firm: Vapotherm Inc.
Product: Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Disposable Patient Circuit that allows water to leak into the center gas lumen
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Vapotherm issued an Initial Notification on August 13, 2014. The letter was updated on August 20, 2014 to include two additional lots. The recall letter notified users that this defect is easily detectable during normal use and the probability of serious injury or death is remote. The letter was sent to raise awareness of the recent increase in incidence rate of this issue and reminded users of the requirement in the operating manual that requires that the cannula be connected to the patient only after the set temperature is reached. The letter also advised patient care personnel not to use, or to discontinue use of any Disposable Patient Circuit if water is observed leaking into the center lumen or from the cannula. They were instructed to replace the device and report the defect to Vapotherm immediately for further investigation. Should you have any questions please contact our technical support team at Email: [email protected] (US) 855.557.8276 (INTL) 1-603.658.5121
Quantity in commerce: 360 units
Distribution: 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2704-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2699-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25
Z-2700-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25
Z-2701-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25
Z-2702-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25
Z-2703-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25
Z-2704-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25
Z-2705-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25
Z-2706-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25

Product code BTT

K072845Class IIPrecision FlowVapotherm, Inc. / cleared 2008-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)