Reported Nov 23, 2022 · Ongoing
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D,…
DeVilbiss Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeVilbiss Healthcare LLC · 100 Devilbiss Dr · Somerset, PA · 15501-2125
Is this the product you have?
- 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen
- Models
125D125D-XB
- Lot codes and dates
- UDI00885304022237
- S/NNew Sales
D22829087DSD22829097DSD22829092DSD22829086DSD22829156DSD22901205DSD22901207DSD22829099DSD22829161DSD22901203DSD22829157DSD22829159DSD22901204DSD22901201DSD22829096DSD22826095DS
- D22826079DS D22826091DS D22826086DS S/NRepair
D22829087DSD22829097DSD22829092DSD22829086DSD22829156DSD22901205DSD22901207DSD22829099DSD22829161DSD22901203DSD22829157DSD22829159DSD22901204DSD22901201DSD22829096DSD22826095DSD22826079DSD22826091DSD22826086DS
- Amount recalled
- 48 units
Where it was sold
Why it was recalled
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
This product could cause temporary or reversible health problems — stop using it.
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