Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Check against the official notice below — it lists the full affected range.
Invacare Corporation has recalled 179 Platinum 5NXG Oxygen Concentrator units (model numbers P5NXG1 and P5NXGC1) distributed across 18 U.S. states between March 2, 2021 and December 31, 2021. The devices were manufactured with labels missing the required "Rx Only" statement. The affected units can be identified by serial number prefixes 21FEXXXXXX, 21JEXXXXXX, 21GEXXXXXX, 21KEXXXXXX, 21HEXXXXXX, 21LEXXXXXX, or 21IEXXXXXX.
The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
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: 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 Quantity: 179 devices Lot/code info: UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.