Invacare Platinum 5NXG Oxygen Concentrator recall
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Why was Invacare Platinum 5NXG Oxygen Concentrator recalled?
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
- Product
- Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
- Recalling firm
- Invacare Corporation
- Quantity
- 179 devices
- Distribution
- Domestic distribution to the following states: ALASKA ARIZONA CALIFORNIA COLORADO GEORGIA IDAHO IOWA KANSAS KENTUCKY MICHIGAN MINNESOTA MISSOURI NEW YORK NORTH CAROLINA OHIO OKLAHOMA PENNSYLVANIA TENNESSEE
- Recall date
- July 20, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)