FDA Device recall Z-1369-2022
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
- FDA Device
- Class III
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class III recall of Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) by Invacare, citing between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1369-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-06-10 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Invacare |
| Distribution | AK, AZ, CA, CO, GA, IA, ID, KS, KY, MI, MN, MO, NC, NY, OH, OK, PA, TN |
Product
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Reason
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Identifiers
| code_info | UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2022%22
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