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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 15 Results
510(K) Number: K103211
 
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AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous re... 1 01/11/2012 Carefusion 211 Inc
Product Name: AVEA® Ventilator. All Models. The affected devices are cleared under K073069 pm 1/2... 1 09/27/2013 Carefusion 211 Inc dba Carefusion
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), int... 1 05/26/2015 Carefusion 211 Inc dba Carefusion
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended ... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist ... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanic... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assis... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically con... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
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