FDAFDA · Food and drugs·Recall number Z-1112-2013
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
Published April 24, 2013 · Recall initiated: March 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion Corporation
- Distributor
- Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
- Lot
- not available
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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