FDA Enforcement
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
Recall: Z-0828-2025
·
Reported January 15, 2025
Enforcement
- Recall Number
- Z-0828-2025
- Event ID
- 95918
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- 3B Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 15, 2025
- Initiation Date
- November 27, 2024
- Classification Date
- January 8, 2025
- Address
- 203 Avenue A Nw Ste 300, Winter Haven, FL, 33881-4540, United States
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
The devices were inadvertently shipped after their expiration date.
Code Info
Lot Code: Lot Number 20170403
Distribution
US: Massachusetts and Arkansas OUS: None
Quantity
5010 units