Recall Z-1369-2022 ยท CAW Generator, Oxygen, Portable
Invacare Corporation
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
| Date | Jun 10, 2022 |
| Status | Open, Classified |
| Reason | 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 | 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203210 | Invacare Platinum 5NXG Oxygen Concentrator Invacare Corporation, Apr 12, 2021 |