OxySure recall
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Why was OxySure 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lots 61-65
- Product
- OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
- Recalling firm
- Oxysure Systems, Inc.
- Quantity
- 1005 units
- Distribution
- Nationwide throughout the US and Chile, Trinidad, China
- Recall date
- August 5, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)