Medical device recalls Moderate risk

ICU Medical Inc recalls Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

Recall date
August 1, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0171-2020
FDA classification
Class II
Brand / firm
ICU Medical Inc
Sold / distributed
US nationwide distribution, and Canada

Why it was recalled

A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.

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

What was recalled

Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

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