The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2823-2020·Announced 2020-08-26

CareFusion Alaris Syringe Module LED Display Dimness Recall

CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because the LED display may show dim segments, 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 defect involves a display issue (dim segments) that could affect monitoring visibility but does not explicitly report injuries or hospitalizations, fitting the Moderate criteria for a Class II recall without severe reported harm.

Plain-English summary

CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units. The recall involves 130,612 units distributed worldwide, including nationwide distribution in the United States and in numerous international countries. The product is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters.

The recall is being conducted because the LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. This defect may affect the clarity of the information displayed to the user.

Healthcare facilities and users should contact CareFusion 303, Inc. for instructions on how to address the issue with the affected modules.

The recalled product

Product
Alaris Syringe Module Model 8110 - 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
Hazard
Affected units
130,612

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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