CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
CareFusion is recalling AVEA GDE upgrade kits because an incorrect fuse may fail, causing loss of power to the ventilator's user interface.
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 922 units of the AVEA GDE upgrade kit (model 12284-PMN) worldwide, including 501 units in the United States. The product is a continuous ventilator intended to mechanically control or assist patient breathing.
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 affected units were distributed in the US and numerous international locations, including Australia, Canada, and the United Kingdom.
Consumers and healthcare facilities should contact CareFusion for instructions on how to address this defect. The source text does not specify a particular action for end-users beyond the recall notification.
The recalled product
- Product
- AVEA GDE upgrade kit, 12284-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 →Related recalls
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