Device Recall Portex First Breath Adult Oxygen Mask with Tubing

Lot Numbers:  09-31  09-33  09-37  09-46  09-48  09-49  10-05  10-08  10-11  10-17

Anesthesiology Devices

1

No

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.

First Breath ¿ Adult Oxygen Mask with Tubing, 213cm (7ft) || Reorder Number: 001421 || 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