DeVilbiss Healthcare LLC: 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

Hazard

An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

Details from the source

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. Quantity: 48 units 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

UPC codes

00885304022237

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.