Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sen...
FDA Recall #Z-1125-2017 — Class II — December 16, 2016
Product 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 for Recall
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Recalling Firm
Covidien LLC — North Haven, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7453 Units
Distribution
Nationwide. Foreign: Belgium Germany France Netherlands
Code Information
Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated