System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-press
FDA device recall Z-0929-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- System 02 Inc
- Reason for recall
- System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'
- Action taken
- Distributors were contacted by telephone with follow up letter sent via registered mail on 5/1/2002. System O2 has volunteered to handle mailings to end users and sub-distributors, and is also establishing a URL to warehouse recall information and forms. All Distributors, sub distributors, retailers and end users will be logged in a data base as Master Distributors forward that information. Results and effectiveness data will be logged in data base for tracking purposes.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 600 units
- Distribution
- Units were sent to 2 direct distributors located in GA.
- Date initiated
- 2003-05-01
- Date posted
- 2003-06-12
- Date terminated
- 2008-10-20
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 (K991569) | 02 Marketing Group, Inc. | 1999-08-03 |