Recall Z-1125-2017— Covidien LLC

Name: FDA recall Z-1125-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2016-12-16, terminated 2018-12-04. It names one FDA 510(k) clearance: K904039. 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.. Reason: Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex..

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Terminated: 2018-12-04
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K904039 — REFLECTANCE SENSOR (RS-10)Nellcor, Inc.·cleared 1990-12-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.