The Recall Desk
HighFDA (Devices)·Z-2722-2020·Announced 2020-08-12

CareFusion Alaris SpO2 Modules Recalled for Cleaning-Related Connector Damage

CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring 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 risk-of-harm product where the hazard is an interruption of therapy or monitoring, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

CareFusion 303, Inc. is recalling 7,854 units of the Alaris SpO2 Module Model 8210 and Model 8220. These devices are modular infusion pump and monitoring systems. The recall covers units distributed worldwide, including the United States, Guam, Puerto Rico, American Samoa, Military Pacific, and numerous international locations.

The recall is due to a risk that 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 should stop using the affected modules and follow the updated cleaning instructions and IUI covers provided by the manufacturer for all serial numbers to prevent further damage.

The recalled product

Product
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
7,854

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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