BEUDAMED
    FDA Recall Terminated

    Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.

    Recall: Z-1288-2018 · Initiated October 17, 2017

    Recall

    Recall Number
    Z-1288-2018
    Event Number
    78568
    Firm
    Southmedic, Inc.
    FEI Number
    3001717360
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 17, 2017
    Posted
    January 25, 2018
    Terminated
    March 29, 2024
    Address
    50 Alliance Blvd, Barrie Canada

    Description

    Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.

    Reason

    Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

    Action

    Customers were notified via letter on October 17, 2017. Instructions included checking inventory for affected devices and quarantining any found, complete and return the Voluntary Recall Notification Confirmation Form, and arrange for the return of any affected products. On February 14, 2018, the recall was expanded and customers were notified. Instructions were the same as the original notification, but updated the Part/Lot information. For further questions, please call 1 (800) 463-7146

    Distribution

    US Distribution to the state of California, and Internationally to Canada and Sweden

    Quantity

    8,871 cases (25 masks per case) total