Z-1369-2022Class III

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

Name: Z-1369-2022 Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Creator: Invacare Corporation
Published: 2022-06-10
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2022-06-10 / Open, Classified / root cause: labeling and UDI

FDA source

Invacare Corporation began a recall of Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) on 2022-06-10. FDA classified it as Class III and gives the reason as "Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1369-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-06-10
Posted: 2022-07-12
Recalling firm: Invacare GmbH
Product: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On June 10, 2022, the firm distributed Medical Device Correction letters to affected providers. Providers were informed that they may have received product with an incorrect label which does not contain the required "Rx Only" symbol. Providers were provided with Provider Acknowledgement Cards which included instructions for applying the correct product label to the device. Providers are responsible for ensuring that the field correction is conducted with their customers. If you have any questions concerning these instructions, please call Invacare's field correction support line at (877) 413-6008 (U.S. Customers) Monday thru Friday, 8 a.m. 5 p.m. EST, for assistance.
Quantity in commerce: 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
Product codes and lots: UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1369-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1369-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code CAW

K203210Class IIInvacare Platinum 5NXG Oxygen ConcentratorInvacare Corporation / cleared 2021-04-12

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)