Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Reported: July 20, 2022 Initiated: June 10, 2022 #Z-1369-2022
Product Description
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
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.
Details
- Recalling Firm
- Invacare Corporation
- Units Affected
- 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
- Location
- Elyria, OH
Frequently Asked Questions
What product was recalled? ▼
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model). Recalled by Invacare Corporation. Units affected: 179 devices.
Why was this product recalled? ▼
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Low. Recall number: Z-1369-2022.
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