Z-1125-2017 Class II Terminated
FDA device recall Z-1125-2017 was initiated by Covidien LLC on Dec 16, 2016 and is designated Class II. 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. The recall status is terminated (terminated Dec 4, 2018). Affected quantity: 7453 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 8, 2017
- Initiation Date
- Dec 16, 2016
- Termination Date
- Dec 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7453 Units
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.
Distribution Pattern
Nationwide. Foreign: Belgium Germany France Netherlands
Code Information
Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1125-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026