Z-2253-2015 Class II Terminated
FDA device recall Z-2253-2015 was initiated by Oxysure Systems, Inc. on June 12, 2015 and is designated Class II. 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. The recall status is terminated (terminated October 19, 2020). Affected quantity: 1005 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2015
- Initiation Date
- June 12, 2015
- Termination Date
- October 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1005 units
Product Description
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
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.
Distribution Pattern
Nationwide throughout the US and Chile, Trinidad, China
Code Information
lots 61-65