The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message."

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…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard

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.

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