The Recall Desk
HighFDA (Devices)·Z-2718-2020·Announced 2020-08-12

CareFusion Alaris Pump Module 8100 Recalled for Cleaning Agent Damage

CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because cleaning agents may damage connectors, causing therapy interruptions.

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 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,' as no specific injuries or illnesses are cited in the source text.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris Pump Module Model 8100, a modular infusion pump and monitoring system. The recall involves 1,332,354 units distributed worldwide, including the United States, Guam, Puerto Rico, American Samoa, and Military Pacific, as well as numerous international locations.

The recall was initiated 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. Such interruptions may result in an infusion stopping with a CHANNEL DISCONNECTED message, triggering audio and visual alarms on the PC Unit and causing an interruption of therapy or monitoring.

Healthcare facilities and users should stop using the affected modules and contact CareFusion 303, Inc. for instructions on updated cleaning procedures and IUI covers, which must be used for all serial numbers during cleaning.

The recalled product

Product
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
1,332,354

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 malfunction

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