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Terminated

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 Recall Z-1125-2017 · Posted None

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeDQA
Date Initiated2016-12-16
Date Terminated2018-12-04
Product Quantity7453 Units

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Nationwide. Foreign: Belgium Germany France Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904039REFLECTANCE SENSOR (RS-10)Nellcor, Inc. · 1990-12-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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