Invacare Corporation Recall 90108
Description: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Invacare Corporation Recall 90108 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1369-2022 |
| Event ID | 90108 |
| Event Description | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) |
| Product Type | 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 |
| Quantity | 179 devices |
| Recall Reason | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required. |
| Device Classification | 20220720 |
| Device Code Info | UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX |
| Center Classification Date | 20220712 |
| Recall Initiation Date | 20220610 |
| Recalling Firm | Invacare Corporation |
| Initial Notification | Letter |
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