60 results
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33ms
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Sources: EU EUDAMED, US FDA
AIRFLOW SMALL ADULT RESUSCITATOR
FDA Adverse Event
Malfunction
·VENTLAB CORP.·Product code BTM·April 18, 2007
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
FDA Enforcement
Class I
·Terminated·Ventlab Corporation·November 7, 2012
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Enforcement
Class I
·Terminated·Ventlab Corporation·November 7, 2012
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Enforcement
Class I
·Terminated·Ventlab Corporation·November 7, 2012
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Enforcement
Class I
·Terminated·Ventlab Corporation·November 7, 2012
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Enforcement
Class I
·Terminated·Ventlab Corporation·November 7, 2012
VENTLAB HYPERINFLATION SYSTEM
FDA Adverse Event
Death
·VENTLAB CORPORATION·Product code NHK·June 29, 2012
AIRFLOW ADULT/PEDIATRIC RESUSCITATOR
FDA Adverse Event
VENTLAB CORPORATION·Product code BTM·December 18, 2009
VENTLAB
FDA Adverse Event
Injury
·VENTLAB CORPORATION·Product code BTM·January 30, 2013
AIRFLOW SMALL ADULT RESUSCITATION AF 5000 SERIES
FDA Adverse Event
Injury
·VENTLAB CORPORATION·Product code BTM·February 14, 2013
ADULT RESUSCITATOR
FDA Adverse Event
Malfunction
·VENTLAB CORPORATION·Product code BTM·December 14, 2010
VENTLAB V CARE 1000 SERIES
FDA Adverse Event
Malfunction
·VENTLAB CORPORATION·Product code BTM·April 6, 2005
AIRFLOW ADULT RESUSCITATION BAG
FDA Adverse Event
Malfunction
·VENTLAB CORPORATION·Product code BTM·April 26, 2013
AIRFLOW ADULT RESUSCITATOR
FDA Adverse Event
Malfunction
·VENTLAB CORPORATION·Product code BTM·May 24, 2013
VENTLAB AIRFLOW SMALL ADULT RESUSCITATOR
FDA Adverse Event
Injury
·VENTLAB CORPORATION·Product code BTM·September 7, 2011
HYPERINFLATION
FDA Adverse Event
Malfunction
·VENTLAB CORPORATION·Product code BTM·May 2, 2013
V-CARE
FDA Adverse Event
Malfunction
·VENTLAB CORPORATION·Product code BTM·January 26, 2006