Class II — CareFusion 303, Inc.
| Recalling firm | CareFusion 303, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 |
| Product | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 |
| Quantity | 76 EtCO2 units |
| Distribution | US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia |
| Initiated | 2019-07-01 |
| Classified | 2019-08-30 |
| Terminated | 2020-09-09 |
| Recall number | Z-2443-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CareFusion 303, Inc. (Z-2443-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83296/
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