Reported Apr 24, 2013 · Terminated
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming,…
Carefusion Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carefusion Corporation · 3750 Torrey View Ct · San Diego, CA · 92130-2622
Is this the product you have?
- Alaris PC unit model 8015 with software version 9.12
- Product UsageThe Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
- Lot codes and dates
- not available
- Amount recalled
- 4,090 total units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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