Events

Recall of Device Recall Rejuv 02 Oxygen Spa.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by System 02 Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26198
  • Event Risk Class
    Class 2
  • Event Number
    Z-0930-03
  • Event Initiated Date
    2003-05-01
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27246
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Generator, Oxygen, Portable - Product Code CAW
  • 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.

Device

Device Recall Rejuv 02 Oxygen Spa.
  • Model / Serial
    All units are under recall.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were sent to 2 direct distributors located in GA.
  • Product 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.
  • Manufacturer
    System 02 Inc

Manufacturer

System 02 Inc
  • Manufacturer Address
    System 02 Inc, 1090 Upper Hembree Rd, Roswell GA 300761140
  • Source
    USFDA