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Salter Labs recalls Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m)
Recalled July 30, 2014 · FDA recall Z-2093-2014 · Salter Labs
Hazard
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather. · FDA Class II
Units
584 units
Sold at
Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.
Description
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Product
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.
Manufacturer(s)
Salter Labs
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →