The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

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: "Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an…"

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 →

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