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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