Invacare recalls specific Canada models of oxygen concentrators due to missing 'Rx Only' label on product labels produced between March 2021 and December 2021. Affected units have serial number prefixes starting with 21F, 21J, 21G, 21K, 21H, or 21L.
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Invacare is recalling certain Canada-specific oxygen concentrators because the product labels produced between March 2021 and December 2021 did not include the required 'Rx Only' statement. This could lead to improper use if the device is not prescribed by a healthcare provider.
The product label did not contain the required 'Rx Only' statement as mandated by regulations. This means the device might be used by individuals who are not prescribed for it, potentially leading to unsafe medical use.
People in Canada who own or use the Invacare Platinum 5NXG Oxygen Concentrator with model numbers P5NXG1 or P5NXGC1 are affected. Those who have the specific serial number prefixes listed are most at risk.
Check for the model numbers P5NXG1 or P5NXGC1 on the device. Look for serial number prefixes starting with 21F, 21J, 21G, 21K, 21H, or 21L. These units were produced between March 2021 and December 2021 in Canada.
Verify the model number and serial number prefixes to confirm if the device is affected.
The product label did not contain the required 'Rx Only' statement as mandated by regulations for units produced between March 2021 and December 2021.
Model numbers P5NXG1 and P5NXGC1 (Canada specific models).
Check for serial number prefixes starting with 21F, 21J, 21G, 21K, 21H, or 21L, which were used for units produced between March 2021 and December 2021 in Canada.
We’ve drafted a message you can send Invacare to request your refund or repair — edit it as you like.
Subject: Recall Z-1369-2022 — Invacare Invacare Hello, I own a Invacare that is covered by recall Z-1369-2022 from Invacare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
