Device 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.
Z-1125-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 76062
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7453 Units
- Official record key
device-enforcement:Z-1125-2017
Official wording
Reason: Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Code information: Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
Distribution pattern: Nationwide. Foreign: Belgium Germany France Netherlands
Derived failure modes
-
Labeling or packaging
Labeling error