CareFusion Alaris PC Unit Infusion Pump Software Recall
CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.
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 involves a medical device defect that could lead to medication administration outside established safety limits, representing a risk of harm where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling 63 units of the Alaris PC unit model 8015, an infusion pump component, due to a software issue in version 9.17. The Alaris PC unit serves as the central programming, monitoring, and power supply component for the Alaris System.
The recall is issued because of a defect in the cancel functionality used during atypical infusion programming. This issue may allow an infusion to start with values that are greater than or less than the hospital-established limits for the specific medication. The affected units were distributed nationwide in the United States.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and contact CareFusion 303, Inc. for instructions on how to address the software defect.
The recalled product
- Product
- Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 63
Distribution
Distributed nationwide across the United States.
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Similar recalls
- SevereCareFusion Recalls Alaris PC Unit 8015 Due to Infusion Interruption Risk
FDA (Devices) · 2017-07-12
- SevereCareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall
FDA (Devices) · 2020-08-12
- HighCareFusion Alaris System PC Unit Recall for Incorrect Patient Weight Data
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