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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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AVEA Ventilator (Catalog Code 17310, 17311, 17312).
The AVEA is intended to provide continuous re...
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1
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01/11/2012
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Carefusion 211 Inc
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Product Name: AVEA® Ventilator.
All Models.
The affected devices are cleared under K073069 pm 1/2...
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1
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09/27/2013
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Carefusion 211 Inc dba Carefusion
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CareFusion AVEA ventilator, all models.
Product Usage:
A continuous ventilator (respirator), int...
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1
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05/26/2015
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Carefusion 211 Inc dba Carefusion
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AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14)
A continuous ventilator intended ...
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1
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06/13/2016
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Carefusion 211 Inc dba Carefusion
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AVEA GDE upgrade kit, 12284-PMN
A continuous ventilator intended to mechanically control or assist ...
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1
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06/13/2016
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Carefusion 211 Inc dba Carefusion
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AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14)
A continuous ventilator...
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1
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06/13/2016
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Carefusion 211 Inc dba Carefusion
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TCA Board, 16542A
A continuous ventilator intended to mechanically control or assist broad spectrum...
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1
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06/13/2016
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Carefusion 211 Inc dba Carefusion
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Gas Delivery Engine (GDE)-1st Generation, 16222-001-99
A continuous ventilator intended to mechanic...
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1
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06/13/2016
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Carefusion 211 Inc dba Carefusion
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Gas Delivery Engine (GDE), 16650A
A continuous ventilator intended to mechanically control or assis...
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1
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06/13/2016
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Carefusion 211 Inc dba Carefusion
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Gas Delivery Engine (GDE)-refurbished, R16650A
A continuous ventilator intended to mechanically con...
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1
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06/13/2016
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Carefusion 211 Inc dba Carefusion
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