Reported Apr 28, 2021 · Ongoing
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health…
Pacific Medical Group Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pacific Medical Group Inc. · 212 Avenida Fabricante · San Clemente, CA · 92672-7538
Is this the product you have?
- Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
- Lot codes and dates
- Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021:
2,452 of 2,452 codes
41050264122780992585699612441233324112333419123338021233421112334212123342131233421412334319123344031233442412334452123346521233471312334833123348961233495012334951123349571233511612335128123351471233515912335163123352121233523212335260123353041233538012335427123354811233551312335522123355701233559612335606123356251233564212335673123357221233575412335790123357921233588312335904123359211233592612335967123359701233600512336011123361561233616512336273123362751233627912336280
- Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021:
- Amount recalled
- 2452
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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