CareFusion Alaris EtCO2 Capnographs Recalled for Calibration Error
CareFusion 303, Inc. is recalling 76 Alaris EtCO2 capnographs because they may have been calibrated with a lower-than-specified CO2 concentration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
CareFusion 303, Inc. is recalling 76 units of the Alaris EtCO2, Model 8300, capnograph. The recall covers specific serial and model numbers, including models 11634567 and 8300ADXeN933.
The recall was initiated because it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2. This calibration error could affect the accuracy of the device's measurements.
The affected units were distributed to facilities in Kentucky, Texas, California, Illinois, Minnesota, North Carolina, Iowa, South Dakota, Kansas, and the District of Columbia, as well as to Australia. Users should contact CareFusion 303, Inc. for instructions on how to address the calibration issue.
The recalled product
- Product
- Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Capnograph
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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