Drug recall
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante…
FDA recall event 87483 · Class I · Pacific Medical Group Inc.
Key facts
| Event ID | 87483 |
|---|---|
| Recall numbers | Z-1375-2021 |
| Recalling firm | Pacific Medical Group Inc. |
| Product type | Devices |
| Products | Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions) |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 24, 2021 |
| Report date | Apr 28, 2021 |
| City | San Clemente |
| State | CA |
| Country | United States |
| FEI number | 3007409280 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: