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U.S. Department of Health and Human Services

Class 2 Device Recall System O2 Portable Oxygen Delivery System (PODS).

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  Class 2 Device Recall System O2 Portable Oxygen Delivery System (PODS). see related information
Date Initiated by Firm May 01, 2003
Date Posted June 12, 2003
Recall Status1 Terminated 3 on October 20, 2008
Recall Number Z-0929-03
Recall Event ID 26198
510(K)Number K991569  
Product Classification Generator, Oxygen, Portable - Product Code CAW
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.
Code Information All units are under recall.
Recalling Firm/
Manufacturer		 System 02 Inc
1090 Upper Hembree Rd
Roswell GA 300761140
For Additional Information Contact John Nycz
678-620-8285
Manufacturer Reason
for Recall		 System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAW and Original Applicant = 02 MARKETING GROUP, INC.
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