22 results
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76ms
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Sources: EU EUDAMED, US FDA
HEATED WIRE CIRCUIT (VENT HUMIDIFIER)
FDA Adverse Event
Malfunction
·VITAL SIGNS COLORADO INC.·Product code BZE·August 20, 2015
VITAL TEMP
FDA Adverse Event
Injury
·VITAL SIGNS COLORADO, INC.·Product code FLL·June 12, 2012
GREENLIGHT II HANDLES
FDA Adverse Event
Death
·VITAL SIGNS COLORADO, INC.·Product code CCW·February 21, 2013
GREENLIGHT HANDLE
FDA Adverse Event
Malfunction
·VITAL SIGNS COLORADO, INC.·Product code CCW·November 4, 2010
DISPOSA-VIEW
FDA Adverse Event
Injury
·VITAL SIGNS COLORADO, INC.·Product code CCX·June 13, 2013
GREENLIGHT II
FDA Adverse Event
Death
·VITAL SIGNS COLORADO, INC.·Product code EQN·May 22, 2009
DISPOSA-VIEW
FDA Adverse Event
Injury
·VITAL SIGNS COLORADO, INC.·Product code CCX·June 11, 2013
STEELITE ISO GREEN LARYNGOSCOPE BLADE
FDA Adverse Event
Death
·VITAL SIGNS COLORADO, INC.·Product code CCW·August 22, 2012
PEDIATRIC BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·VITAL SIGNS COLORADO, INC.·Product code OFP·August 23, 2013
Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code CCW·December 20, 2010
Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.
FDA Recall
Terminated
·Vital Signs Devices, a GE Healthcare Company·Product code BYD·April 29, 2011
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code KAK·August 17, 2012
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·March 13, 2015
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code CAH·December 26, 2013
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·March 13, 2015
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.
FDA Enforcement
Class II
·Terminated·Vital Signs Colorado Inc.·January 29, 2014
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Enforcement
Class II
·Terminated·Vital Signs Colorado Inc.·May 6, 2015