Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1369-2022 — Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

U.S. FDA — Device Enforcement · United States · 2022-06-10 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1369-2022
Date of alert
2022-06-10
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Invacare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00841447112075
Reported risk: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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