Recall Z-0229-2023 ยท CAW Generator, Oxygen, Portable
DeVilbiss Healthcare LLC
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
| Date | Nov 11, 2022 (initiated Sep 19, 2022) |
| Status | Open, Classified |
| Reason | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) |
| Root cause | Under Investigation by firm |
| Action | DeVilbiss notified Distributors/End Users by telephone on 9/19/22. Providers of portable oxygen concentrators, identified as recipient of affected units, were contacted asking them to return any finished good units in their possession with affected serial numbers to DeVilbiss for evaluation. A replacement unit will be provided once unit possession and shipping confirmation is received. If any unit has been supplied by the provider to an end user, the provider is being requested to contact the end user to request them to stop using the unit and to replace the unit immediately. If you have an |
| Quantity | 48 units |
| Distribution | US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator Devilbiss Healthcare, LLC, Mar 23, 2018 |