FDA-Device2021-04-28Class I
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Pacific Medical Group Inc.
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.
Sold states
Distribution US nationwide.
Affected count
2452
Manufactured in
212 Avenida Fabricante, N/A, San Clemente, CA, United States
Products
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2021Don't want to check this manually?
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