Medical device recalls Moderate risk

Ivenix, Inc. recalls Ivenix Infusion System (IIS)

Recall date
April 22, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1381-2022
FDA classification
Class II
Brand / firm
Ivenix, Inc.
Sold / distributed
US Nationwide distribution in the states of NJ and WI.

Why it was recalled

Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

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

What was recalled

Ivenix Infusion System (IIS)

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