The Recall Desk
ModerateFDA (Devices)·Z-2822-2020·Announced 2020-08-26

CareFusion Alaris Pump Module 8100 Recalled for Dim LED Display Segments

CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific defect involves dim display segments, which is a functional issue rather than a direct physical hazard like a structural failure or contamination.

Plain-English summary

CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units. The recall is due to a defect where segments on the LED display, which provides infusion or patient monitoring values, may appear dim.

The affected product is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters. The recall covers 1,442,097 units distributed worldwide, including in the United States and numerous international countries. All serial numbers are affected.

Healthcare facilities and users should contact CareFusion 303, Inc. for instructions on how to address the issue with the dim LED display segments.

The recalled product

Product
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump Module
Hazard
Affected units
1,442,097

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 55 states specifically:

Part of a larger recall action

This product is one of 5 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · display defect

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