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.
This recall has been terminated (originally issued December 16, 2016).
- Company
- Covidien Llc
- Recall Initiated
- December 16, 2016
- Terminated
- December 4, 2018
- Recall Number
- Z-1125-2017
- Quantity
- 7453 Units
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide. Foreign: Belgium Germany France Netherlands
Lot / Code Info
Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
Root Cause
Process control
Action Taken
Medtronic 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.