Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Numb
Summary
The FDA issued a Class II for Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot M by 3B Medical, Inc.. Reason: The devices were inadvertently shipped after their expiration date..
Details
Source
Device Recall
External ID
Z-0828-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
Product Description
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
Lot/Code Info: Lot Code: Lot Number 20170403
Quantity Affected: 5010 units
Reason for Recall
The devices were inadvertently shipped after their expiration date.
Distribution
US: Massachusetts and Arkansas OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-27
Company
Winter Haven, FL
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 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3B Medical, Inc. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
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 (3B Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3B Medical, Inc. have FDA actions?
3B Medical, Inc. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0828-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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