CareFusion 303, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0534-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: December 5, 2013

Date Posted: January 1, 2014

Recall Number: Z-0534-2014

Event ID: 66865

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4824 total units (4242 units in US)

Code Information:

not available

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated