125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
FDA Recall Z-0229-2023 · Posted 2022-11-11
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Recalling FirmDeVilbiss Healthcare LLC
Recall StatusOpen, Classified
Product CodeCAW
Date Initiated2022-09-19
Product Quantity48 units
Reason for Recall
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Firm Action
DeVilbiss notified Distributors/End Users by telephone on 9/19/22. Providers of portable oxygen concentrators, identified as recipient of affected units, were contacted asking them to return any finished good units in their possession with affected serial numbers to DeVilbiss for evaluation. A replacement unit will be provided once unit possession and shipping confirmation is received.
If any unit has been supplied by the provider to an end user, the provider is being requested to contact the end user to request them to stop using the unit and to replace the unit immediately.
If you have any questions, call 800-338-1988.
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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