Recalls / —
—#152087
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.
- FDA product code
- DQA — Oximeter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K904039
- Affected lot / code info
- Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
Why it was recalled
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- Distribution pattern
- Nationwide. Foreign: Belgium Germany France Netherlands
Timeline
- Recall initiated
- 2016-12-16
- Terminated
- 2018-12-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.