Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel — Class I medical device recall Z-1375-2021
Ongoing recall by Pacific Medical Group Inc., reported 2021-04-28, distributed nationwide. Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, wit
| Recall number | Z-1375-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pacific Medical Group Inc., San Clemente, CA, United States |
| Recall initiated | 2021-03-24 |
| Classified | 2021-04-19 |
| Reported by FDA | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,452 |
| Reason classes | packaging |
| Model numbers | 8100 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1375-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.