BEUDAMED
    FDA Recall Terminated

    OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.

    Recall: Z-2253-2015 · Initiated June 12, 2015

    Recall

    Recall Number
    Z-2253-2015
    Event Number
    71524
    Firm
    Oxysure Systems, Inc.
    FEI Number
    3004167951
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 12, 2015
    Posted
    July 24, 2015
    Terminated
    October 19, 2020
    Address
    10880 John W Elliott Dr, Ste 600, Frisco, TX, 75033-3281

    Description

    OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.

    Reason

    Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.

    Action

    The recalling firm will notify their affected customers via email beginning the week of 6/15/15. The recall notification will have a response for to be completed by the consignee. The recall notification calls for the customers to dispose of the affected product according to the MSDS.

    Distribution

    Nationwide throughout the US and Chile, Trinidad, China

    Quantity

    1005 units