The Recall Desk
SevereFDA (Devices)·Z-1892-2016·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 loss of power to the user interface module.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4.

Plain-English summary

CareFusion 211 Inc dba Carefusion is recalling 922 units of the AVEA Standard ventilator-refurbished (R17311-xx). The recall covers units distributed worldwide, including 501 units in the United States.

The recall is due to a potential risk where an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board may fail or blow. This failure 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 broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

The source text does not specify specific actions for consumers or patients. The recall is classified as Class I by the FDA.

The recalled product

Product
AVEA Standard ventilator-refurbished, R17311-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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