Drug recall
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10…
FDA recall event 76062 · Class II · Covidien LLC
Key facts
| Event ID | 76062 |
|---|---|
| Recall numbers | Z-1125-2017 |
| Recalling firm | Covidien LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Dec 16, 2016 |
| Report date | Feb 8, 2017 |
| Termination date | Dec 4, 2018 |
| City | North Haven |
| State | CT |
| Country | United States |
| FEI number | 1219930 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: