CareFusion Recalls BD Alaris EtCO2 Modules Due to Monitoring Interruption Risk
CareFusion 303, Inc. is recalling 680 BD Alaris EtCO2 modules because a component defect may interrupt patient monitoring.
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. The hazard involves the interruption of patient monitoring, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
CareFusion 303, Inc. is recalling 680 units of the BD Alaris System EtCO2 module. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The device is intended for use with intubated and nonintubated adult, pediatric, and neonatal patients.
The recall is due to a component defect that may result in the interruption of patient monitoring. The affected units were distributed nationwide in the United States, including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, and WI. The affected model is the EtCO2 8300, with lot/serial numbers 10002682711, 10002720508, 1000287042, and 10002882569.
Healthcare facilities should check their inventory for the affected serial numbers and stop using the recalled modules. Consumers and patients should contact their healthcare provider or the manufacturer for further instructions regarding the replacement or repair of these devices.
The recalled product
- Product
- BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- Affected units
- 680
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 (5)
- Model: EtCO2 8300
- Lot/Serial numbers: 10002682711
- 10002720508
- 1000287042
- 10002882569
Distribution
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