FDA recall Z-1369-2022

Invacare Corporation · Class III · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2022-06-10
Report date: 2022-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Elyria, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2022