CareFusion 303, Inc. recalls Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the…

Recall date

November 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1520-2017

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.

Why it was recalled

Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.