The National Agency for Food and Drug Administration and Control has been notified of the recall of AVEA ventilator by Care Fusion. The recall was due to a faulty fuse on the ventilator s’ alarm board.
The AVEA ventilator system is a versatile critical care ventilator intended for continuous breathing support in neonatal, pediatrics, and adult patients with complex respiratory diseases.
Product name: AVEA ventilator
Product manufacturer: CAREFUSION
22745 Savi Ranch Parkway
Yorba Linda CA 92887
Manufacturing Dates: November 13, 2015 to January 4, 2016
Distribution Dates: December 16, 2015 to February 15, 2016
Product Description Product Numbers
AVEA Standard with compressor ventilator- refurbished R17312-xx (xx= 0-14)
AVEA Comprehensive ventilator 17310-xx (xx= 0-14)
AVEA Standard ventilator 17311-xx (xx= 0-14)
AVEA standard with compressor ventilator 17312-xx (x= 0-14)
AVEA Comprehensive ventilator – refurbished R17310-xx (xx= 0-14)
AVEA Standard ventilator – refurbished R17310- xx (xx=0-14)
AVEA Standard with compressor ventilator-refurbished R17312-xx (xx-0-14)
TCA Board 16542A
GDE-1st generation 16222-001-99
AVEA GDE/UIM upgrades kit 12283-PMN
- the ventilator may shut down unexpectedly which will lead to the patient not getting enough oxygen resulting to suffocation and possible death of the patient
Healthcare Providers’ action
- Discontinue use of device
NAFDAC…………Safeguarding the health of the Nation!!!