Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Nu...
FDA Recall #Z-0828-2025 — Class II — November 27, 2024
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
Reason for Recall
The devices were inadvertently shipped after their expiration date.
Recalling Firm
3B Medical, Inc. — Winter Haven, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5010 units
Distribution
US: Massachusetts and Arkansas OUS: None
Code Information
Lot Code: Lot Number 20170403
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated