Reported Feb 8, 2017 · Terminated

Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is…

Covidien LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Covidien
  • Nellcor SpO2 Forehead Sensor Item CodeRS10; 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
Lot codes and dates
  • Lot Numbers
    • 161510095H
    • 161620089H
    • 161690203H
    • 161760132H
    • 161900091H
    • 161970090H
    • 162040107H
    • 162110103H
    • 162320191H
    • 162390212H
Amount recalled
7453 Units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 4, 2018 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.