The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2825-2020·Announced 2020-08-26

CareFusion Alaris EtCO2 Module Recall for Dim LED Display Segments

CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the hazard involves a display defect (dim segments) that may affect monitoring visibility. This aligns with the rubric for moderate severity, as it is a functional defect without reported injuries or deaths, but it is not merely cosmetic as it affects the primary output of the device.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris EtCO2 Module Model 8300. The recall involves 40,671 units distributed worldwide, including nationwide distribution across the United States and various international locations. The product is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters.

The reason for the recall is that the LED display, which provides infusion or patient monitoring values, may have segments that appear dim. This defect could impact the clarity of the information displayed to healthcare providers.

Healthcare facilities and users should check their inventory for the affected Alaris EtCO2 Module Model 8300 units. CareFusion 303, Inc. is the recalling firm and is responsible for managing the recall process.

The recalled product

Product
Alaris EtCO2 Module Model 8300 - 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
40,671

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 →

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