Reported Oct 9, 2013 · Terminated
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on…
Carefusion 211 Inc. dba Carefusion
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carefusion 211 Inc dba Carefusion · 22745 Savi Ranch Pkwy · Yorba Linda, CA · 92887-4668
Is this the product you have?
- Product NameAVEA¿ 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 breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device
- Lot codes and dates
- All Models
- Serial Numbers
3,257 of 3,257 codes
BCV01807AEV01754AFV01269AFV01692AFV01694AFV02330AFV02338AFV02339AFV02349AFV02350AFV02515AGV01817AGV01818AGV02135AGV02189AGV02296AGV02306AGV02344AHV03372AJV01001AJV01242AJV01292AJV01297AJV01300AJV01301AJV01701AJV01702AJV01703AJV01716AJV01718AJV01732AJV01733AJV01746AJV01748AJV01749AJV01819AJV01820AJV01824AJV02086AJV02088AJV02089AJV02090AJV02091AJV02093AJV02097AJV02099AJV02208AJV02306AJV02311AJV02320AJV02321AJV02322AJV02323AJV02324AJV02325AJV02326AJV02327AJV02328AJV02329AJV02330
- Amount recalled
- 19,546 units
Where it was sold
Why it was recalled
Stop using this product now
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 field correction of the affected devices to correct the error.
Using this product could cause serious injury, illness or death — stop using it now.
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