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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 Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mec... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or ass... 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
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechani... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically ... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended ... 1 06/13/2016 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
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