Carefusion Recalls Alaris PC Unit 8015 Due to Bolus Programming Risk
Carefusion is recalling 4,090 Alaris PC unit model 8015 devices with software version 9.12 due to potential data loss risks during bolus programming.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Carefusion Corporation is recalling 4,090 Alaris PC unit model 8015 devices equipped with software version 9.12. These units serve as the central programming, monitoring, and power supply components for the Alaris System. The recall was initiated because Carefusion identified a potential risk associated with bolus programming in this specific software version.
The hazard involves the automation of infusion pump parameter input from either an electronic medical record (EMR) or the Alaris Auto-ID module. When used for a continuous infusion with a bolus dose option, this process may result in a loss of information from the Guardrails Data system. The affected units were distributed worldwide, including the United States, Australia, and Canada.
Healthcare facilities and users should contact Carefusion Corporation for further instructions on how to address the software issue. The source text does not specify a particular action for end-users beyond the recall notification.
The recalled product
- Product
- Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
- Manufacturer
- Carefusion Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 4,090
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)
- not available
Distribution
Distributed nationwide across the United States.
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