Oxysure Systems, Inc. recalls OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
- Recall date
- June 12, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2253-2015
- FDA classification
- Class II
- Brand / firm
- Oxysure Systems, Inc.
- Sold / distributed
- Nationwide throughout the US and Chile, Trinidad, China
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
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