Z-1369-2022 Class III Ongoing
FDA device recall Z-1369-2022 was initiated by Invacare Corporation on June 10, 2022 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 179 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- June 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179 devices
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.
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
Code Information
UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX