The Recall Desk
HighFDA (Devices)·Z-1889-2016·Announced 2016-06-22

CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing a loss of power to the user interface module.

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 component failure could lead to loss of power to the user interface, representing a risk of harm where injury has not yet been reported.

Plain-English summary

CareFusion 211 Inc dba Carefusion is recalling AVEA Standard ventilators (model 17311-xx, where xx = 0 - 14). The recall involves 922 units total, with 501 units distributed in the United States and the remainder distributed worldwide in various countries including Australia, Canada, and the United Kingdom.

The recall was initiated because the ventilators contain an incorrect F1 fuse on the Transducer Communication Alarm (TCA) Board. This fuse may fail or blow, which can cause a loss of power to the User Interface Module (UIM). The AVEA Standard ventilator is a continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen.

Consumers and healthcare facilities should contact CareFusion for instructions on how to address this defect. The source text does not specify specific actions such as stopping use or returning the device, but users should follow the manufacturer's guidance.

The recalled product

Product
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Manufacturer
Carefusion 211 Inc dba Carefusion
Category
Medical Device — Ventilator
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Carefusion 211 Inc dba Carefusion 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 12 products in this recall →

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