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Recall Observatory FDA recall evidence

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

December 16, 2016

Class II

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

    reason.labeling_packaging · v1.0.0

    Labeling error