The Recall Desk
SevereFDA (Devices)·Z-1362-2020·Announced 2020-03-11

CareFusion Alaris PCA Module Recalled for Software Errors

CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units. The recall affects 83,015 units distributed nationwide in the United States and in various international regions, including Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia, and the European Union. The affected software versions are 12.1.0, and 9.33 and prior.

The recall is due to several software errors. These errors may result in the inability to edit settings, infusion interruptions, the absence of low battery alarms, unrecognized infusion completion, and medication concentrations that are higher or lower than prescribed orders.

Healthcare facilities and users of these devices should contact CareFusion 303, Inc. for further instructions on how to address the software issues.

The recalled product

Product
CareFusion Alaris PCA Module, Model 8120
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
83,015

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 (2)

  • Software versions 12.1.0
  • and 9.33 and prior

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 4 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 4 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · software error

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