Alaris EtCO2 Module Model 8300 — Class II medical device recall Z-2825-2020
Ongoing recall by CareFusion 303, Inc., reported 2020-08-26, distributed nationwide. LED display, which provides infusion or patient monitoring values, on the module may have segments that appear
| Recall number | Z-2825-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2020-06-30 |
| Classified | 2020-08-19 |
| Reported by FDA | 2020-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 40,671 |
| Model numbers | 8300 |
Product
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Reason for recall
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
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-2825-2020. 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.