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Covidien LLC recalls Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is ind
Recalled February 8, 2017 · FDA recall Z-1125-2017 · Covidien
Hazard
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. · FDA Class II
Units
7453 Units
Sold at
Nationwide. Foreign: Belgium Germany France Netherlands
Description
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Product
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.
Manufacturer(s)
Covidien LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →