BEUDAMED
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    Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

    FDA Recall
    Terminated ·King Systems Corp.·Product code BYG·January 24, 2011

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012

    Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA The kit contains oxygen masks and blood pressure cuffs use on pediatric patients

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code BYG·April 26, 2011

    First Breath ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag & Tubing, 213cm (7ft.) 50/CA Reorder Number: 001431 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYG·February 11, 2011

    First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213cm (7ft) (Non-latex) 50/CA Re-Order Number: 001423 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYG·February 11, 2011

    Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BYG·April 3, 2017

    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DYG·December 21, 2018

    Right Heart Catheter Product Line: Catalog Number 604239-------------426D1009I.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYG·May 25, 2005

    Right Heart Catheter Product Line: Catalog Number 608054------------827D1006I 4P BBM RMM Cath.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYG·May 25, 2005

    Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code BYG·May 10, 2017

    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DYG·December 21, 2018

    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DYG·May 11, 2012

    First Breath Adult Face Tent (Non-latex) 50/CA Reorder Number: 001490 Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after surgery

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYG·February 11, 2011

    Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/7' tube and safety vent - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.

    FDA Recall
    Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code BYG·March 25, 2011

    Right Heart Catheter Product Line: Catalog Number 604000------417D1006I.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYG·May 25, 2005

    Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYG·June 5, 2007