FDAFDA · Food and drugs·Recall number Z-0229-2023
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Published November 23, 2022 · Recall initiated: September 19, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- DeVilbiss Healthcare LLC
- Distributor
- US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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