FDA Device recall Z-2443-2019
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
- FDA Device
- Class II
- terminated
- Published 2019-09-11
On 2019-09-11 the FDA classified a Class II recall of Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 by Carefusion 303, citing calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2443-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-01 |
| Published | 2019-09-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carefusion 303 |
| Distribution | CA, DC, IA, IL, KS, KY, MN, NC, SD, TX |
Product
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Reason
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Identifiers
| code_info | Serial #/Model # 15098573 11634567; 15111502 11634567; 15096360 11634567; 15098699 11634567; 15099681 1163…Serial #/Model # 15098573 11634567; 15111502 11634567; 15096360 11634567; 15098699 11634567; 15099681 11634567; 15096411 11634567; 15091045 11634567; 15095827 11634567; 15090452 11634567; 15091016 11634567; 15091061 11634567; 15102989 11634567; 15096388 11634567; 15098536 11634567; 15098577 11634567; 15099809 11634567; 15099880 11634567; 15100031 11634567; 15101644 11634567; 15101802 11634567; 15102453 11634567; 15102532 11634567; 15091069 11634567; 15091118 11634567; 15102694 11634567; 15095732 11634567; 15095813 11634567; 15095837 11634567; 15095838 11634567; 15095745 11634567; 15096145 11634567; 15096189 11634567; 15096165 11634567; 15096179 11634567; 15096789 11634567; 15098732 11634567; 15101800 11634567; 15101856 11634567; 15101878 11634567; 15101902 11634567; 15101956 11634567; 15101984 11634567; 15102450 11634567; 15102465 11634567; 15102463 11634567; 15102547 11634567; 15102604 11634567; 15102565 11634567; 151026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2443-2019%22
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