Home / Recalls / Invacare Corporation / Z-1369-2022

Z-1369-2022 Class III Ongoing

Recalled by Invacare Corporation — Elyria, OH

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

Other recalls by Invacare Corporation

  • Z-1251-2024 Class II — Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Mo (January 22, 2024)
  • Z-2445-2023 Class II — DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve (June 15, 2023)
  • Z-1130-2022 Class II — Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V (March 30, 2022)
  • Z-0445-2022 Class II — Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Nu (November 12, 2021)
  • Z-0446-2022 Class II — Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model (November 12, 2021)
  • Z-0447-2022 Class II — Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module M (November 12, 2021)
  • Z-0514-2021 Class II — Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory (October 30, 2020)
  • Z-0549-2019 Class II — Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P Th (November 16, 2018)
  • Z-2218-2017 Class II — Assist Bed Rail - 6632 (April 25, 2017)
  • Z-1182-2017 Class II — Bariatric Bed - BAR600IVC (December 2, 2016)