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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.

FDA Recall Z-0930-03 · Posted 2003-06-12

Recalling FirmSystem 02 Inc
Recall StatusTerminated
Product CodeCAW
Date Initiated2003-05-01
Date Terminated2008-10-20
Product Quantity1400 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Units were sent to 2 direct distributors located in GA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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