OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
FDA device recall Z-2253-2015 · posted 2015-07-24 · Terminated
Recall details
- Recalling firm
- Oxysure Systems, Inc.
- Reason for recall
- 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.
- Action taken
- The recalling firm will notify their affected customers via email beginning the week of 6/15/15. The recall notification will have a response for to be completed by the consignee. The recall notification calls for the customers to dispose of the affected product according to the MSDS.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 1005 units
- Distribution
- Nationwide throughout the US and Chile, Trinidad, China
- Date initiated
- 2015-06-12
- Date posted
- 2015-07-24
- Date terminated
- 2020-10-19
- Location
- Frisco, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 (K052396) | Oxysure Systems, Inc. | 2005-12-09 |