BEUDAMED
    FDA Recall 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 · Initiated December 16, 2016

    Recall

    Recall Number
    Z-1125-2017
    Event Number
    76062
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 16, 2016
    Terminated
    December 4, 2018
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    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.

    Action

    Medtronic initiated on December 16, 2016. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department. Complete a Recalled Product Return Form (Attachment A, included with letter) and submit it to customer service so a Returned Goods Authorization number (RGA#) can be issued. Questions contact Medtronic representative or customer service at 800-882-5878.

    Distribution

    Nationwide. Foreign: Belgium Germany France Netherlands

    Quantity

    7453 Units