FDA (Devices) recall action 74111

Carefusion 211 Inc dba Carefusion recalled 12 products on 2016-06-22

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2016-06-22
Critical: 1
Units: —

Why these products were recalled

CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

The agency’s own wording, quoted from the enforcement report.

1–12 of 12

SevereFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
CriticalFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
HighFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
HighFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
HighFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
CareFusion is recalling AVEA GDE upgrade kits because an incorrect fuse may fail, causing loss of power to the ventilator's user interface.
Product
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
HighFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
HighFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
SevereFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
CareFusion is recalling AVEA Ventilator upgrade kits because an incorrect fuse may fail, causing loss of power to the User Interface Module.
Product
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
HighFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling 922 AVEA Ventilators worldwide because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
SevereFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing loss of power to the User Interface Module.
Product
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
LowFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states
HighFDA (Devices)··2016-06-22
CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing a loss of power to the user interface module.
Product
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Distribution
0 states