CareFusion Alaris EtCO2 Model 8300: Calibration Issue May Cause Inaccurate Readings
CareFusion recalls Alaris EtCO2 Model 8300 devices with specific serial numbers due to potential calibration errors using lower CO2 concentrations during manufacturing, which may cause inaccurate blood gas readings.
Lower-risk recall
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Contact the company
What happened, in plain English
CareFusion is recalling certain Alaris EtCO2 Model 8300 devices that may have been calibrated incorrectly during manufacturing. This could lead to inaccurate blood gas readings during medical procedures, potentially affecting patient care. Read more at govinfonow.com/recall/67537-carefusion-alaris-etco2-model-8300-calibration-issue-may-cause-inaccurate.
Source Summary by GovInfoNow · govinfonow.com/recall/67537-carefusion-alaris-etco2-model-8300-calibration-issue-may-cause-inaccurate · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2443-2019
Cite this page
“CareFusion Alaris EtCO2 Model 8300: Calibration Issue May Cause Inaccurate Readings.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67537-carefusion-alaris-etco2-model-8300-calibration-issue-may-cause-inaccurate. Based on FDA recall #Z-2443-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2443-2019%22&limit=1).
Why it’s dangerous
The capnographs may have been calibrated using a lower than specified concentration of CO2 during manufacturing. This could result in inaccurate blood gas readings during medical procedures, potentially affecting patient care decisions.
Who’s affected
Healthcare professionals using the Alaris EtCO2 Model 8300 devices with specific serial numbers listed in the recall notice. Patients receiving care from these devices may be at risk of inaccurate blood gas measurements.
How to tell if you have this one
Check for the model numbers 11634567 or 8300ADXeN933 on the device. The serial numbers listed in the recall notice (e.g., 15098573, 15102989) are associated with affected units.
- Brand
CareFusion- Category
Medical device
What to do — step by step
Check Device Model
Identify if your device has model numbers 11634567 or 8300ADXeN933.
Verify Serial Number
Compare your device's serial number with the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in 9 states and D.C., and outside the U.S.
FDA distribution: “US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, District of Columbia, Illinois, Iowa, Kansas, Kentucky, Minnesota, North Carolina, South Dakota, Texas.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if my device is affected?
The recall does not include a specific remedy, so you should check with CareFusion directly for further instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2443-2019 (July 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2443-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.