Recall Z-0929-03 ยท CAW Generator, Oxygen, Portable
System 02 Inc
System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White P
| Date | Jun 12, 2003 (initiated May 1, 2003) |
| Status | Terminated |
| Reason | System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.' |
| Root cause | Other |
| Action | 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. |
| Quantity | 600 units |
| Distribution | Units were sent to 2 direct distributors located in GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991569 | HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 02 Marketing Group, Inc., Aug 3, 1999 |