PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 15, 2025 Initiated: November 27, 2024 #Z-0828-2025

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.

Details

Recalling Firm
3B Medical, Inc.
Units Affected
5010 units
Distribution
US: Massachusetts and Arkansas OUS: None
Location
Winter Haven, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by 3B Medical, Inc.. Units affected: 5010 units.
Why was this product recalled?
The devices were inadvertently shipped after their expiration date.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 15, 2025. Severity: Moderate. Recall number: Z-0828-2025.