Drug recall
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
FDA recall event 83296 · Class II · CareFusion 303, Inc.
Key facts
| Event ID | 83296 |
|---|---|
| Recall numbers | Z-2443-2019 |
| Recalling firm | CareFusion 303, Inc. |
| Product type | Devices |
| Products | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 |
| Initiation date | Jul 1, 2019 |
| Report date | Sep 11, 2019 |
| Termination date | Sep 9, 2020 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2016493 |
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: