Alaris EtCO2 — Class II medical device recall Z-2443-2019
Terminated recall by CareFusion 303, Inc., reported 2019-09-11, distributed in CA, DC, IA, IL, KS, KY, MN, NC…. Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a
| Recall number | Z-2443-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2019-07-01 |
| Classified | 2019-08-30 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-09-09 |
| Distributed | CA, DC, IA, IL, KS, KY, MN, NC, SD, TX |
| Countries outside the US | AU |
| Quantity | 76 etco |
| UPC / GTIN / UDI-DI | 10885403830013 |
| Model numbers | 11634567, 15098573, 8300, 8300ADXEN933 |
Product
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2443-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.