BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.

    Recall: Z-1125-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1125-2017
    Event ID
    76062
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2017
    Initiation Date
    December 16, 2016
    Classification Date
    February 2, 2017
    Termination Date
    December 4, 2018
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.

    Reason

    Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.

    Code Info

    Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H

    Distribution

    Nationwide. Foreign: Belgium Germany France Netherlands

    Quantity

    7453 Units