The Recall Desk
CriticalFDA (Devices)·Z-1891-2016·Announced 2016-06-22

CareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect

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

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

CareFusion 211 Inc dba CareFusion is recalling AVEA Comprehensive ventilators (refurbished, model R17310-xx) due to a potential risk associated with an incorrect F1 fuse on the Transducer Communication Alarm (TCA) Board. The defect may cause the fuse to fail or blow, resulting in a loss of power to the User Interface Module (UIM).

The recall involves 922 units total, with 501 units distributed in the United States. The devices were distributed worldwide, including in Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordan, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.

The FDA has classified this recall as Class I. Consumers and healthcare facilities should contact CareFusion for instructions on how to address the defect.

The recalled product

Product
AVEA Comprehensive ventilator-refurbished, R17310-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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