Home / Recalls / DeVilbiss Healthcare LLC / Z-0229-2023

Z-0229-2023 Class II Ongoing

Recalled by DeVilbiss Healthcare LLC — Somerset, PA

Recall Details

Product Type
Devices
Report Date
November 23, 2022
Initiation Date
September 19, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48 units

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)

Distribution Pattern

US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.

Code Information

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

Other recalls by DeVilbiss Healthcare LLC

  • Z-1558-2023 Class II — DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025 (March 9, 2023)
  • Z-0724-2023 Class II — DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q (November 18, 2022)
  • Z-2246-2016 Class II — DeVilbiss Model 7305P-D Powered Suction Unit (May 23, 2016)
  • Z-1949-2014 Class III — DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Ap (May 13, 2014)
  • Z-2319-2013 Class II — DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 (March 7, 2013)