Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Reported: April 28, 2021 Initiated: March 24, 2021 #Z-1375-2021
Product Description
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.
Details
- Recalling Firm
- Pacific Medical Group Inc.
- Units Affected
- 2452
- Distribution
- Distribution US nationwide.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions). Recalled by Pacific Medical Group Inc.. Units affected: 2452.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Critical. Recall number: Z-1375-2021.
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