Device Recall Portex First Breath ADULT Elongated NonRebreather Oxygen Mask with 1L Reservoir Bag & Tubing,

  • Modèle / numéro de série
    Lot Numbers:  09-50  10-05  10-09  10-10  10-11  10-17
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
  • Description du dispositif
    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
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Smiths Medical, Hythe, Hythe, Kent United Kingdom
  • Société-mère du fabricant (2017)
  • Source
    USFDA