The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2716-2020·Announced 2020-08-12

CareFusion Alaris System PC Unit Model 8000 Recall for Cleaning Agent Damage

CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.

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 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to therapy interruption.

Plain-English summary

CareFusion 303, Inc. is recalling 37,141 units of the Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system. The recall is due to a potential defect where cleaning agents may damage the Inter-Unit Interface (IUI) Connectors.

If the IUI Connectors are damaged, it may lead to an interruption of communication or power between the PC Unit and its modules. This can result in an infusion stopping with a 'CHANNEL DISCONNECTED' message, triggering an audio/visual alarm on the PC Unit and causing an interruption of therapy or monitoring.

The affected units were distributed worldwide, including the United States (nationwide, Guam, Puerto Rico, American Samoa, and Military Pacific) and numerous international countries. The source text does not specify a consumer action or remediation step, but the recall is classified as Class I by the FDA.

The recalled product

Product
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
37,141

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 (20)

  • During cleaning
  • 2326382
  • 2326385
  • 2326387
  • 3668143
  • 2326400
  • 2326401
  • 2326402
  • 2326416
  • 2326418
  • 2326419
  • 2326423
  • 2326647
  • 2326664
  • 2326819
  • 2326821
  • 2326834
  • 2326837
  • 2326842
  • 2326873

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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Same manufacturer · CareFusion 303, Inc.

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