The Recall Desk
HighFDA (Devices)·Z-2723-2020·Announced 2020-08-12

CareFusion Alaris Auto ID Module Recall Due to Cleaning Agent Damage

CareFusion is recalling Alaris Auto ID Modules because cleaning agents may damage connectors, causing infusion interruptions and therapy stops.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a defect can lead to the interruption of therapy or monitoring. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system. The recall involves 17,767 units distributed worldwide, including the United States and its territories, and numerous international countries.

The recall is issued because cleaning agents may damage the Inter-Unit Interface (IUI) Connectors. This damage can lead to an interruption of communication or power between the PC Unit and the modules. As a result, an infusion may stop with a CHANNEL DISCONNECTED message, triggering an audio/visual alarm on the PC Unit and causing an interruption of therapy or monitoring.

Healthcare facilities and users of the affected devices should stop using the Alaris Auto ID Module Model 8600 and follow the updated cleaning instructions and IUI covers provided by the manufacturer for all serial numbers.

The recalled product

Product
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
17,767

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)

  • During cleaning

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 →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · device failure

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