Thursday, 01 December 2016 07:18

Recall of AVEA ventilator Care Fusion

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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 details:

            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

Recalled Product:

                        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

GDE                                                                                           16650A

GDE-refurbished                                                                          R16650A

AVEA GDE/UIM upgrades kit                                                        12283-PMN

Possible risks

  • 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
  • Report all serious adverse events or side effects related to the use of this device to NAFDAC PRASCOR (20543-TOLL FREE FROM ALL NETWORK) or via individual case safety report forms or via email: This email address is being protected from spambots. You need JavaScript enabled to view it. .

 

NAFDAC…………Safeguarding the health of the Nation!!!

Read 1894 times Last modified on Thursday, 01 December 2016 07:44

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