Recall Z-1369-2022— Invacare Corporation
Class III · Ongoing
Class III FDA medical device recall by Invacare Corporation, initiated 2022-06-10. It names one FDA 510(k) clearance: K203210. Product: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model). Reason: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required..
- Recalling firm
- Invacare Corporation
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2022-06-10
- Firm location
- Elyria, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.