The Recall Desk
SevereFDA (Devices)·Z-1898-2016·Announced 2016-06-22

CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

CareFusion is recalling AVEA Ventilator upgrade kits 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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.

Plain-English summary

CareFusion 211 Inc dba Carefusion is recalling the AVEA GDE/UIM upgrade kit (12283-PMN). The recall involves 922 units total, with 501 units distributed in the United States and the remainder distributed worldwide in 34 other countries.

The recall was initiated because the AVEA Ventilator Transducer Communication Alarm (TCA) Board contains an incorrect F1 fuse. This fuse may fail or blow, which can cause a loss of power to the User Interface Module (UIM). The AVEA 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 healthcare providers, nor does it report any illnesses or injuries associated with this defect. The recall is classified as Class I by the FDA.

The recalled product

Product
AVEA GDE/UIM upgrade kit, 12283-PMN 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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