The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface…"

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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