Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Incre

FDA device recall Z-0930-03 · posted 2003-06-12 · Terminated

Recall details

Recalling firm

System 02 Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

CAW

Quantity affected

1400 units

Distribution

Units were sent to 2 direct distributors located in GA.

Date initiated

2003-05-01

Date posted

2003-06-12

Date terminated

2008-10-20

Location

Roswell, GA