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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Nellcor SpO2 Forehead Sensor

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 Class 2 Device Recall Covidien Nellcor SpO2 Forehead Sensorsee related information
Date Initiated by FirmDecember 16, 2016
Create DateFebruary 02, 2017
Recall Status1 Terminated 3 on December 04, 2018
Recall NumberZ-1125-2017
Recall Event ID 76062
510(K)NumberK904039 
Product Classification Oximeter - Product Code DQA
ProductCovidien 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.
Code Information Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
FEI Number 1219930
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactSAME
203-492-5000
Manufacturer Reason
for Recall		Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
FDA Determined
Cause 2		Process control
ActionMedtronic initiated on December 16, 2016. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien)  195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department. Complete a Recalled Product Return Form (Attachment A, included with letter) and submit it to customer service so a Returned Goods Authorization number (RGA#) can be issued. Questions contact Medtronic representative or customer service at 800-882-5878.
Quantity in Commerce7453 Units
DistributionNationwide. Foreign: Belgium Germany France Netherlands
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQA
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