Recall Z-1369-2022
Invacare Corporation · initiated June 10, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Codes / lots: UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-1369-2022
- Initiated
- June 10, 2022
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 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
- Recalling firm
- Invacare Corporation, Elyria, OH