CareFusion Recalls Alaris EtCO2 Module 8300 Due to Calibration Error
CareFusion is recalling 157 Alaris EtCO2 Module 8300 units because they may have been tested with high CO2 concentrations, potentially causing incorrect measurements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the device is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
CareFusion 303, Inc. is recalling 157 units of the Alaris EtCO2 Module, Model 8300. This medical device is a capnograph used to continuously monitor end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
The recall was initiated because the modules may have been tested during service using a higher than specified concentration of CO2. This testing error could lead to incorrect measurements of CO2 by the device.
The affected units were distributed in the United States. Consumers and healthcare facilities should check their inventory for the specific serial codes listed in the official recall notice and contact CareFusion for further instructions.
The recalled product
- Product
- Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- Affected units
- 157
Distribution
Distribution scope not specified by the agency.
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