96 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The Tri-Flo Subglottic Suction System
FDA Enforcement
Class I
·Terminated·Vyaire Medical·August 29, 2018
The Tri-Flo Subglottic Suction System
FDA Recall
Terminated
·Vyaire Medical·Product code BSY·June 20, 2018
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
FDA Recall
Terminated
·Vyaire Medical·Product code LGZ·March 13, 2019
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
FDA Recall
Terminated
·Vyaire Medical·Product code LGZ·March 13, 2019
Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.
FDA Recall
Terminated
·Medline Industries Inc·Product code N/A·May 3, 2019
Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
FDA Recall
Terminated
·Vyaire Medical·Product code BTT·November 29, 2014
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
FDA Recall
Terminated
·Vyaire Medical·Product code BTT·November 29, 2014
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
FDA Recall
Terminated
·Vyaire Medical·Product code BTT·November 29, 2014
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
FDA Recall
Terminated
·Vyaire Medical·Product code BTT·November 29, 2014
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.
FDA Recall
Terminated
·Vyaire Medical·Product code BTM·May 8, 2018
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.
FDA Recall
Terminated
·Vyaire Medical·Product code BTM·May 8, 2018
AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017