Medical device recalls Moderate risk

CareFusion 303, Inc. recalls Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply…

Recall date
May 12, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2064-2016
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
Distributed US (nationwide) and in Canada.

Why it was recalled

A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.

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 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

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