Agency classClass IOur severity:Severe FDA (Devices)·Z-2719-2020·Announced 2020-08-12

CareFusion Alaris Syringe Module Recall Due to Cleaning Agent Damage

CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.

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 122,423 units of the Alaris Syringe Module Model 8110, 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.

Damage to these connectors may lead to an interruption of communication or power between the PC Unit and the modules. This 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. The source text does not specify a date range or specific lot numbers, but notes that updated cleaning instructions and IUI covers must be used for all serial numbers during cleaning.

The recalled product

Product: Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Infusion Pump
Hazard: device-malfunction
therapy-interruption
Affected units: 122,423

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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