FDA recall Z-1375-2021

Product

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

Reason for recall

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.

Distribution

Distribution US nationwide.

Key facts

Status

Ongoing

Initiation date

2021-03-24

Report date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2021