Invacare Platinum 5NXG Oxygen Concentrator Recall Due to Missing Rx Only Label Statement
Invacare Corporation is recalling 179 Platinum 5NXG Oxygen Concentrator units distributed across 18 states because product labels are missing the required "Rx Only" statement.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III FDA medical device recall involving a missing required regulatory labeling statement on prescription oxygen concentrator units. No adverse events or injuries have been reported. The issue is classified as a minor labeling defect, meeting the criteria for Moderate severity.
Plain-English summary
Invacare Corporation has recalled 179 Platinum 5NXG Oxygen Concentrator units (model numbers P5NXG1 and P5NXGC1) distributed across 18 states.
The recalled devices' product labels do not include the required "Rx Only" statement. This labeling omission occurred for units manufactured between March 2, 2021 and December 31, 2021.
The affected devices were distributed to patients and healthcare providers in Alaska, Arizona, California, Colorado, Georgia, Idaho, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, and Tennessee. Affected units can be identified by specific serial number prefixes (21FE, 21JE, 21GE, 21KE, 21HE, 21LE, 21IE).
Patients currently using this device should verify they have the "Rx Only" statement on their device documentation. If unsure about their device, contact Invacare Corporation or their healthcare provider. No adverse events or injuries related to this issue have been reported.
The recalled product
- Product
- Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
- Manufacturer
- Invacare Corporation
- Hazard
- labeling-error
Distribution
Distribution scope not specified by the agency.
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