Recall Z-2253-2015
Oxysure Systems, Inc. · initiated June 12, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Codes / lots: lots 61-65
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-2253-2015
- Initiated
- June 12, 2015
- Posted by FDA
- July 24, 2015
- Terminated
- October 19, 2020
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 1005 units
- Distribution
- Nationwide throughout the US and Chile, Trinidad, China
- Recalling firm
- Oxysure Systems, Inc., Frisco, TX