125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
- Company
- Devilbiss Healthcare Llc
- Recall Initiated
- September 19, 2022
- Posted
- November 11, 2022
- Recall Number
- Z-0229-2023
- Quantity
- 48 units
- Firm Location
- Somerset, PA
Reason for Recall
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Distribution
US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Lot / Code Info
UDI: 00885304022237 S/N: New Sales D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS S/N: Repair D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS
Root Cause
Under Investigation by firm
Action Taken
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.