Recall Z-2253-2015 ยท CAW Generator, Oxygen, Portable
Oxysure Systems, Inc.
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
| Date | Jul 24, 2015 (initiated Jun 12, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1005 units |
| Distribution | Nationwide throughout the US and Chile, Trinidad, China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052396 | OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 Oxysure Systems, Inc., Dec 9, 2005 |