Device Recall Portex First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing,

  • Modelo / Serial
    Lot Numbers:  09-34  09-35  09-41  09-47  10-10  10-17
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Smiths Medical, Hythe, Hythe, Kent United Kingdom
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA