DeVilbiss Healthcare LLC Recall 90950
Description: 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
DeVilbiss Healthcare LLC Recall 90950 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0229-2023 |
| Event ID | 90950 |
| Event Description | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB |
| Product Type | Devices |
| Distribution | US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada. |
| Quantity | 48 units |
| Recall Reason | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) |
| Device Classification | 20221123 |
| Device 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 |
| Center Classification Date | 20221111 |
| Recall Initiation Date | 20220919 |
| Recalling Firm | DeVilbiss Healthcare LLC |
| Initial Notification | Telephone |
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