FDA Recall Terminated

Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.

Recall: Z-0930-03 · Initiated May 1, 2003

Recall

Recall Number
Z-0930-03
Event Number
26198
Firm
System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140
FEI Number
3003038637
Product Code
CAW
Status
Terminated
Root Cause
Other
Initiated
May 1, 2003
Posted
June 12, 2003
Terminated
October 20, 2008

Description

Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.

Reason

System 02 oxygen flow rate found to be inadequate and Rejuv02 Home Oxygen Bar contains 'Adulterated Labeling.'

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.

Distribution

Units were sent to 2 direct distributors located in GA.

Quantity

1400 units