The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2273-2013·Announced 2013-10-09

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.

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¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a…"

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…
Manufacturer
Carefusion 211 Inc dba Carefusion
Category
Medical Device — Ventilator
Hazard
Affected units
19,546

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Carefusion 211 Inc dba Carefusion

See all →

Similar recalls