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Pacific Medical Group Inc. recalls Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health So
Recalled April 28, 2021 · FDA recall Z-1375-2021 · Pacific Medical Group
Hazard
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. · FDA Class I
Units
2452
Sold at
Distribution US nationwide.
Description
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.
Product
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Manufacturer(s)
Pacific Medical Group Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →