Agency classClass IOur severity:Severe FDA (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.

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 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: device-malfunction
therapy-interruption
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 →

Same manufacturer · CareFusion 303, Inc.

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