Device Recall Portex First Breath Pediatric Aerosol Mask (NonLatex)

Lot Numbers:  09-35 09-48 10-06 10-17  10-21

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 ¿ Pediatric Aerosol Mask (Non-Latex) 50/CA || Reorder Number: 001476 || 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.