FDA recall Z-0229-2023

DeVilbiss Healthcare LLC · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2022-09-19
Report date
2022-11-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Somerset, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2023