• July 17 2012 
    Ventilator
    A leak may occur in the patient breathing circuit or system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value.
    CareFusion issued the following update regarding its previously announced voluntary recall of EnVe ventilators. The FDA has classified this action as a Class 1 recall.
    # / Press release: http://www.fda.go...
  • July 2 2012 
    Infant Breathing Circuit (Ventilation Product)
    Can develop cracks and leaks in the closed ventilation system.
    CareFusion issued the following update regarding its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall.
    # / Press release: http://www.fda.go...
  • Jan. 20 2012 
    Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License
    potential risks associated with the Cortical Stimulator Control Unit, SSU Amplifier and related software applications
    # / Press release: http://www.fda.go...
  • Dec. 22 2011 
    AVEA Ventilators
    Potential risk is associated with certain AVEA ventilators and affected replacement parts
    # / Press release: http://www.fda.go...
  • Oct. 19 2011 
    Ventilators
    Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death
    # / Press release: http://www.fda.go...
  • Oct. 15 2010 
    PC Units
    may experience an intermittent communication error, freezing screen
    CareFusion (NYSE: CFN), a leading global medical device company, issued the following update regarding its previously disclosed recall of approximately 17,000 Alaris® PC units model 8015 manufactured or serviced between December 2008 and September 2009. The FDA has classified this action as a Class I recall.
    # / Press release: http://www.fda.go...
  •  
    PC Units
    may experience an intermittent communication error, freezing screen
    # / Press release: http://www.fda.go...

Recalls Count

7

The Reasons

  1. may experience an intermittent communication error, freezing screen (2)
  2. potential risks associated with the Cortical Stimulator Control Unit, SSU Amplifier and related software applications (1)
  3. Potential risk is associated with certain AVEA ventilators and affected replacement parts (1)
  4. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death (1)
  5. Can develop cracks and leaks in the closed ventilation system. (1)
  6. A leak may occur in the patient breathing circuit or system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value. (1)

^Above are for recalls since 2009.