The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2826-2020·Announced 2020-08-26

CareFusion Alaris SpO2 Module Recall for Dim LED Display Segments

CareFusion 303, Inc. is recalling Alaris SpO2 Modules because the LED display may have 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 hazard involves a display defect that may affect the visibility of monitoring values. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving potential risk of harm without confirmed adverse events.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris SpO2 Module Model 8210 and Model 8220. The recall involves 8,558 units distributed worldwide, including nationwide distribution across the United States and various international territories.

The recall was initiated because the LED display, which provides infusion or patient monitoring values, may have segments that appear dim. This defect could potentially impact the clarity of the information displayed to healthcare caregivers.

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 SpO2 Module Model 8210 and Model 8220 - 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 — Patient Monitoring
Hazard
Affected units
8,558

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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