# FDA recall Z-1651-2021

> **The Biomed Guys** · Class I · device recall initiated 2021-03-25.

## Product

Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

## Reason for recall

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts.  Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

## Distribution

Us distribution to the states of IN and TX.

## Key facts

- **Recall number:** Z-1651-2021
- **Recalling firm:** The Biomed Guys
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-25
- **Report date:** 2021-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clarksville, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2021

## Citation

> AI Analytics. FDA recall Z-1651-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1651-2021. Source: US FDA. Licensed CC0.

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