medical MODERATE Updated 2017-02-08

Covidien LLC recalls Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; T

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Recalled 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.

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Hazard / Issue

Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall