# FDA recall Z-2204-2021

> **BioMedical Equipment Service Co (BMES)** · Class I · device recall initiated 2021-02-25.

## Product

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

## Reason for recall

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

## Distribution

The affected products were distributed to the following US states:  CA, IL, IN, KY, LA, NJ, NV, OH, and PA.

## Key facts

- **Recall number:** Z-2204-2021
- **Recalling firm:** BioMedical Equipment Service Co (BMES)
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-25
- **Report date:** 2021-08-18
- **Termination date:** 2024-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2204-2021

## Citation

> AI Analytics. FDA recall Z-2204-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2204-2021. Source: US FDA. Licensed CC0.

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