CareFusion Recalls AVEA Ventilators for Barometric Pressure Error
CareFusion is voluntarily correcting AVEA ventilators to fix a barometric pressure compensation error identified during a proactive review.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary field correction initiated by the manufacturer to fix a specific error (barometric pressure compensation) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
CareFusion 211 Inc dba Carefusion is voluntarily initiating a field correction for AVEA ventilators, all models. The recall involves 19,546 units that were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international countries.
The recall was initiated after a proactive complaint review identified a potential risk associated with the use of these ventilators at higher altitudes. Specifically, an error was found in the barometric pressure compensation of the devices. CareFusion is correcting this error to ensure the devices function as intended.
The affected devices are Class II medical devices cleared under K073069 and K103211. A continuous ventilator is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient b
- Manufacturer
- Carefusion 211 Inc dba Carefusion
- Category
- Medical Device — Ventilator
- Affected units
- 19,546
Distribution
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