FDA-Device2014-07-30Class II
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
Salter Labs
Hazard
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Sold states
Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.
Affected count
584 units
Manufactured in
2365 Camino Vida, Carlsbad, CA, United States
Products
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2093-2014Don't want to check this manually?
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