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Open, Classified

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

FDA Recall Z-1369-2022 · Posted None

Recalling FirmInvacare Corporation
Recall StatusOpen, Classified
Product CodeCAW
Date Initiated2022-06-10
Product Quantity179 devices

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.

Firm Action

On June 10, 2022, the firm distributed Medical Device Correction letters to affected providers. Providers were informed that they may have received product with an incorrect label which does not contain the required "Rx Only" symbol. Providers were provided with Provider Acknowledgement Cards which included instructions for applying the correct product label to the device. Providers are responsible for ensuring that the field correction is conducted with their customers. If you have any questions concerning these instructions, please call Invacare's field correction support line at (877) 413-6008 (U.S. Customers) Monday thru Friday, 8 a.m. 5 p.m. EST, for assistance.

Root Cause

Labeling Change Control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203210Invacare Platinum 5NXG Oxygen ConcentratorInvacare Corporation · 2021-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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