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Oxysure Systems, Inc. recalls OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Recalled August 5, 2015 · FDA recall Z-2253-2015 · Oxysure Systems
Hazard
Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes. · FDA Class II
Units
1005 units
Sold at
Nationwide throughout the US and Chile, Trinidad, China
Description
Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.
Product
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Manufacturer(s)
Oxysure Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →