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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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.
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