CareFusion Alaris System PC Unit Recall for Incorrect Patient Weight Data
CareFusion 303, Inc. is recalling 69,693 Alaris System PC Units because the RESTORE feature may incorrectly populate patient weight for specific infusion modules.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 defect involves incorrect patient weight data in a medical device used for infusion, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
CareFusion 303, Inc. is recalling 69,693 units of the Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19. The recall was initiated because a patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
The affected units were distributed nationwide in the United States and in Canada. The recall covers specific serial numbers listed in the official FDA notice. The Alaris System PC Unit serves as the central programming, monitoring, and power supply component for the Alaris System.
Healthcare facilities should check their inventory for the affected serial numbers and software versions. Users should contact CareFusion 303, Inc. for further instructions on how to address the software defect.
The recalled product
- Product
- Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 69,693
Distribution
Distributed nationwide across the United States.
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Similar recalls
- HighCareFusion Alaris PC Unit Infusion Pump Software Recall
FDA (Devices) · 2015-06-24
- SevereCareFusion Recalls Alaris PC Unit 8015 Due to Infusion Interruption Risk
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