FDA-Device2017-02-08Class II
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.
Covidien LLC
Hazard
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Sold states
Nationwide. Foreign: Belgium Germany France Netherlands
Affected count
7453 Units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1125-2017Don't want to check this manually?
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