Z-0929-03

System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable...

Name: Z-0929-03 System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable...
Creator: System 02 Inc
Published: 2003-05-01
License: https://open.fda.gov/license/

System 02 Inc / initiated 2003-05-01 / Terminated / root cause: labeling and UDI

FDA source

System 02 Inc began a recall of System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified... on 2003-05-01. The reason FDA records is "System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0929-03
Status: Terminated
Initiated: 2003-05-01
Posted: 2003-06-12
Terminated: 2008-10-20
Recalling firm: System 02 Inc
Product: 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 Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Operating Instructions xxx, Directions: xxx, Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.xxx, Applications: Unit is intended to provide oxygen for emergency use. Manufactured by System O2, Inc., 1090 Upper Hembree Road, Roswell, GA 30076-1140.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'
Root cause tag: labeling and UDI
FDA 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 in commerce: 600 units
Distribution: Units were sent to 2 direct distributors located in GA.
Product codes and lots: All units are under recall.

Product code CAW

K991569Class IIHome/commercial Oxygen Unit by System O202 Marketing Group, Inc. / cleared 1999-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)