The Recall Desk
HighFDA (Devices)·Z-2721-2020·Announced 2020-08-12

CareFusion Alaris EtCO2 Module Recall Due to Cleaning Agent Damage

CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.

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 may result in the interruption of therapy or monitoring. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling 38,982 units of the Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system. The recall is due to a risk that cleaning agents may damage the Inter-Unit Interface (IUI) Connectors on the device.

Damage to these connectors may lead to an interruption of communication or power between the PC Unit and the modules. This failure 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 nationwide in the United States (including Guam, Puerto Rico, American Samoa, and Military Pacific) and in numerous other countries. During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers to prevent this issue.

The recalled product

Product
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
38,982

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.

See all →

Same hazard · device malfunction

See all →