# FDA recall Z-1375-2021

> **Pacific Medical Group Inc.** · Class I · device recall initiated 2021-03-24.

## 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

- **Recall number:** Z-1375-2021
- **Recalling firm:** Pacific Medical Group Inc.
- **Classification:** Class I
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1375-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1375-2021. Source: US FDA. Licensed CC0.

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