CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
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 for loss of power to a critical module, representing a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
CareFusion 211 Inc dba Carefusion is recalling 922 units of the AVEA Standard with Compressor ventilator-refurbished (R17312-xx, where xx = 0-14). The recall affects 501 units in the United States and the remainder distributed worldwide in 34 other countries.
The recall was initiated because the ventilators may 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 is a continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect. Users should refer to the official FDA recall notice for specific instructions on how to address the affected units.
The recalled product
- Product
- AVEA Standard with Compressor ventilator-refurbished, R17312-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 →Related recalls
Same manufacturer · Carefusion 211 Inc dba Carefusion
See all →- HighCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- SevereCareFusion 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 Standard Ventilators Due to Fuse Defect
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- HighCareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
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