Reported Jun 3, 2015 · Terminated
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically…
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?
- CareFusion AVEA ventilator, all models
- Product UsageA continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas
- Lot codes and dates
- Serial No.BBV
AKV01874AGV01443AEV02197AKV02580AEV02375BBV01304BBV01303AJV02510AJV02502AGV02650AFV01802AFV01792AFV01400AFV01361AEV01622AEV01608AKV01915BBV03730BBV03557BBV03556BBV03554BBV03553
AGV2,864 of 2,864 codes
3558BBV01406BBV01396AHV01880AGV02205BBV01432AFV01657AFV01655AFV01647BAV05234AHV03069AGV02249BBV03797BAV06514BDV01011BDV01000BCV01938BAV04011BAV04010BAV04009BAV04005BAV04004BAV04003BAV04002BAV01313AKV04053AJV02289BAV04021AEV02264AEV02225AEV02205ADV06091AKV02569AHV01206AKV04351AKV04349AKV02550AGV01385AHV03128ADV04116BBV06059BBV06057BAV05153AFV01492BBV01620BDV01371BAV06447BAV06446BAV06445AEV01724AEV01712BAV06463AEV01694AJV02446AGV02139BAV04188BAV04187AKV01153AKV01147AEV02720
- Serial No.
- Amount recalled
- 15,905 units total (5,670 units in US)
Where it was sold
Why it was recalled
Stop using this product now
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
Using this product could cause serious injury, illness or death — stop using it now.
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