Recall Z-0229-2023— DeVilbiss Healthcare LLC

Name: FDA recall Z-0229-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-19

Class II · Ongoing

Class II FDA medical device recall by DeVilbiss Healthcare LLC, initiated 2022-09-19. It names one FDA 510(k) clearance: K172648. Product: 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB. Reason: An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway).

Recalling firm: DeVilbiss Healthcare LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-09-19
Firm location: Somerset, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K172648 — Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC·cleared 2018-03-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.