125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 12
Summary
The FDA issued a Class II for 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration o by DeVilbiss Healthcare LLC. Reason: An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway).
Details
Source
Device Recall
External ID
Z-0229-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
Product Description
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
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
Quantity Affected: 48 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-19
Company
Somerset, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DeVilbiss Healthcare LLC has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DeVilbiss Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DeVilbiss Healthcare LLC have FDA actions?
DeVilbiss Healthcare LLC has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0229-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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