CareFusion Alaris System PC Unit Recall for Battery Alarm Failure
CareFusion is recalling Alaris System PC units because low battery alarms may fail to trigger before the battery discharges, stopping all infusion channels.
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 involves a risk-of-harm product (infusion pump) where the failure of battery alarms could lead to the cessation of medical treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris System PC unit, model numbers 8000 and 8015. This device serves as the central programming, monitoring, and power supply component for the Alaris infusion pump System. The recall involves 613,800 total units, with 575,221 units distributed in the United States.
The recall was initiated due to reports that the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is fully discharged. When this occurs, all infusion channels are stopped. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including the US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, the Middle East, and Canada. Users of these devices should contact CareFusion 303, Inc. for further instructions on how to address the alarm malfunction.
The recalled product
- Product
- Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- 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 (1)
- all units
Distribution
Distributed nationwide across the United States.
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Similar recalls
- SevereCareFusion Alaris System PC Unit Model 8000 Infusion Pump Recall
FDA (Devices) · 2020-08-12
- ModerateCareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error
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