FDA-Device2014-01-01Class I
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.
CareFusion 303, Inc.
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.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
Affected count
4824 total units (4242 units in US)
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0534-2014Don't want to check this manually?
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