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.
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
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.
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.
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.
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.
Identify if your device has model numbers 11634567 or 8300ADXeN933.
Compare your device's serial number with the list of affected units provided in the recall notice.
The recall is due to potential calibration errors during manufacturing using a lower than specified concentration of CO2, which may cause inaccurate blood gas readings.
Check for model numbers 11634567 or 8300ADXeN933 and compare your serial number with the list of affected units provided in the recall notice.
The recall does not include a specific remedy, so you should check with CareFusion directly for further instructions.
We’ve drafted a message you can send CareFusion to request your refund or repair — edit it as you like.
Subject: Recall Z-2443-2019 — CareFusion CareFusion Hello, I own a CareFusion that is covered by recall Z-2443-2019 from CareFusion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
