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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential risk of power loss to the user interface, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
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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See all →- HighCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
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- CriticalCareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect
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- HighCareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
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- HighCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
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