Medical device recalls Moderate risk

CareFusion 303, Inc. recalls Alaris PC Unit, Model 8015

Recall date
June 12, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2671-2017
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.

Why it was recalled

BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.

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

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