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U.S. Department of Health and Human Services

Class 3 Device Recall Invacare Platinum 5NXG Oxygen Concentrator

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  Class 3 Device Recall Invacare Platinum 5NXG Oxygen Concentrator see related information
Date Initiated by Firm June 10, 2022
Create Date July 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1369-2022
Recall Event ID 90108
510(K)Number K203210  
Product Classification Generator, oxygen, portable - Product Code CAW
Product Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Code Information UDI-DI: 00841447112075  Serial Number Prefixes:  21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX  
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact Invacare Corporation
877-413-6008
Manufacturer 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.
FDA Determined
Cause 2		 Labeling Change Control
Action On June 10, 2022, the firm distributed Medical Device Correction letters to affected providers. Providers were informed that they may have received product with an incorrect label which does not contain the required "Rx Only" symbol. Providers were provided with Provider Acknowledgement Cards which included instructions for applying the correct product label to the device. Providers are responsible for ensuring that the field correction is conducted with their customers. If you have any questions concerning these instructions, please call Invacare's field correction support line at (877) 413-6008 (U.S. Customers) Monday thru Friday, 8 a.m. 5 p.m. EST, for assistance.
Quantity in Commerce 179 devices
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CAW and Original Applicant = Invacare Corporation
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