The Recall Desk
ModerateFDA (Devices)·Z-2824-2020·Announced 2020-08-26

CareFusion Alaris PCA Module 8120 Recalled for Dim LED Display Segments

CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120 units because the LED display may show dim segments, 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. The hazard involves a display defect (dim segments) that may affect the visibility of monitoring values, but no specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity recall involving a potential risk of harm without confirmed adverse events.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris PCA Module Model 8120. This medical device 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.

The recall is due to a defect where the LED display, which provides infusion or patient monitoring values, may have segments that appear dim. This issue could potentially impact the clarity of the information displayed to caregivers.

The recall involves 89,497 units with all serial numbers. The products were distributed worldwide, including nationwide distribution in the United States and in numerous other countries. Healthcare facilities and users should stop using the affected modules and contact CareFusion 303, Inc. for instructions on how to proceed.

The recalled product

Product
Alaris PCA Module Model 8120 - 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
89,497

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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