Device product
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Z-2253-2015
Product summary
- Event
- Event 71524
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1005 units
- Official record key
device-enforcement:Z-2253-2015
Official wording
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.
Code information: lots 61-65
Distribution pattern: Nationwide throughout the US and Chile, Trinidad, China
Derived failure modes
-
Unknown
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.