OxySure Model 615 disposable replacement cartridges, for portable oxygen generator recall — FDA Z-2253-2015
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.
Overview of recall records associated with Oxysure Systems, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
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.
This page summarizes recall records in which the official source identifies Oxysure Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.