Product Safety Recalls

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Invacare Corporation Recall 90108

Description: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

Invacare Corporation Recall 90108 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1369-2022
Event ID90108
Event DescriptionInvacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Product TypeDevices
DistributionDomestic 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
Quantity179 devices
Recall ReasonBetween March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Device Classification20220720
Device Code InfoUDI-DI: 00841447112075 Serial Number Prefixes: 21FEXXXXXX 21JEXXXXXX 21GEXXXXXX 21KEXXXXXX 21HEXXXXXX 21LEXXXXXX 21IEXXXXXX
Center Classification Date20220712
Recall Initiation Date20220610
Recalling FirmInvacare Corporation
Initial Notification Letter
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