The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3140-2024·Announced 2024-09-25

Alaris EtCO2 Module Model 8300 Recalled Due to Bent Connector

CareFusion 303, Inc. recalls 180 Alaris EtCO2 Module Model 8300 units with potentially bent female connectors that may prevent device operation, risking delays in infusion and monitoring.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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: This is an FDA Class II recall of a medical device with a functional defect (bent connector) that could prevent device operation and delay critical patient infusion or monitoring. No injuries or adverse events have been reported; the hazard is a risk-of-harm situation where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling 180 units of the Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system. The affected devices are identified by specific model numbers, UDI-DI codes, and serial numbers.

Some affected devices may have bent female IUI connectors. A bent connector may prevent the device from operating, potentially delaying the start of infusion therapy or monitoring.

The recalled devices were distributed worldwide, including across all U.S. states and territories, as well as to facilities in the United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand. No adverse events or patient injuries have been reported related to 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 and Monitoring System
Hazard
Affected units
180

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)

  • Model Number: 8300 UDI-DI codes: 10885403830020

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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