The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1359-2020·Announced 2020-03-11

CareFusion Alaris PC Unit Software Error Recall

CareFusion is recalling Alaris PC units due to software errors that may cause infusion interruptions, alarm failures, 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 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: "1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion…"

Plain-English summary

CareFusion 303, Inc. is recalling the CareFusion Alaris System, specifically Alaris PC unit models 8000 and 8015. The recall involves approximately 870,070 units distributed nationwide in the United States and internationally to countries including Canada, Australia, New Zealand, and various regions in Europe, Asia, and the Middle East.

The recall is due to several software errors. These issues can result in the inability to edit settings, interruptions in KVO (Keep Vein Open) rates or therapy, and the failure of low battery alarms or infusion stopping functions. Additionally, medium priority alarms may not be recognized, and custom concentration data entry errors may lead to medication concentrations that are higher or lower than ordered.

Healthcare facilities and users should contact CareFusion for instructions on how to address these software issues. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
870,070

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 (5)

  • Model 8000
  • software versions 9.5 and prior
  • Model 8015
  • 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 →

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