CareFusion Recalls AVEA Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing 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 classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
CareFusion 211 Inc dba Carefusion is recalling 922 units of the AVEA Ventilator, specifically the TCA Board model 16542A. The recall affects 501 units in the United States and the remainder distributed worldwide to countries including Australia, Canada, Japan, 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 result in a loss of power to the User Interface Module (UIM). The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen.
Healthcare providers and facilities should contact CareFusion for instructions on how to address the defect. The source text does not specify a particular action for individual consumers, as these are medical devices typically managed by institutional procurement or maintenance teams.
The recalled product
- Product
- TCA Board, 16542A 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 →Related recalls
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