FDAClass IIFebruary 8, 2017

Covidien Nellcor SpO2 Forehead Sensor recall: Labeling Error

Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous…

Why was Covidien Nellcor SpO2 Forehead Sensor recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H

Product
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous…
Recalling firm
Covidien LLC
Quantity
7453 Units
Distribution
Nationwide. Foreign: Belgium Germany France Netherlands
Recall date
February 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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