Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
FDA Recall Z-2704-2014 · Posted 2014-09-25
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Recalling FirmVapotherm, Inc.
Recall StatusTerminated
Product CodeBTT
Date Initiated2014-08-13
Date Terminated2015-10-02
Product Quantity360 units
Reason for Recall
Disposable Patient Circuit that allows water
to leak into the center gas lumen
Firm 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
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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