The Recall Desk
ModerateFDA (Devices)·Z-0534-2014·Announced 2014-01-01

CareFusion Recalls Alaris PC Units Due to System Error Messages

CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.

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 I, which typically indicates a low risk of adverse health consequences. The defect involves a system error message and alarm, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris PC unit, models 8000 and 8015, which are used as the central programming, monitoring, and power supply component for the Alaris System. The recall involves 4,824 total units, with 4,242 units distributed in the United States and the remainder distributed internationally to Canada, the Netherlands, and Australia.

The recall is being conducted because the Alaris PC unit may produce an audible alarm and display a System Error message. The source text does not specify any reported injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and consumers who have these specific units should contact CareFusion for further instructions on how to resolve the issue.

The recalled product

Product
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia

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)

  • not available

Distribution

Distributed nationwide across the United States.