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FDAFDA · Food and drugs·Recall number Z-0534-2014

Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.

Published January 1, 2014 · Recall initiated: December 5, 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

CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
CareFusion 303, Inc.
Distributor
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
Lot
not available
Risk classification
Class I
Area (FDA)
device
Country
United States

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