FDAFDA · Food and drugs·Recall number Z-1125-2017
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.
Published February 8, 2017 · Recall initiated: December 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- Nationwide. Foreign: Belgium Germany France Netherlands
- Lot
- Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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