Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Summary
The FDA issued a Class III for Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canad by Invacare Corporation. Reason: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required..
Details
Source
Device Recall
External ID
Z-1369-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Lot/Code Info: UDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
Quantity Affected: 179 devices
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-10
Company
Elyria, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Invacare Corporation has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Invacare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Invacare Corporation have FDA actions?
Invacare Corporation has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1369-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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