Medical device recalls Moderate risk

CareFusion 303, Inc. recalls Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central progra…

Recall date
May 13, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1811-2015
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
US Nationwide Distribution

Why it was recalled

An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.

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 PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

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