BEUDAMED
    FDA Recall Terminated

    Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    Recall: Z-2703-2014 · Initiated August 13, 2014

    Recall

    Recall Number
    Z-2703-2014
    Event Number
    69116
    Firm
    Vapotherm, Inc.
    FEI Number
    3012971441
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 13, 2014
    Posted
    September 25, 2014
    Terminated
    October 2, 2015
    Address
    22 Industrial Dr, Ste 1, Exeter, NH, 03833-4557

    Description

    Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    Reason

    Disposable Patient Circuit that allows water to leak into the center gas lumen

    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

    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.

    Quantity

    22042 units