Pacific Medical Group Inc. recalls Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health S…

Recall date

March 24, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1375-2021

FDA classification

Class I

Brand / firm

Pacific Medical Group Inc.

Sold / distributed

Distribution US nationwide.

Why it was recalled

Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)