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

Recall date

December 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1125-2017

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Nationwide. Foreign: Belgium Germany France Netherlands

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.