3B Medical, Inc.: Device Recall
Recall #Z-0828-2025 · 11/27/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0828-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- 3B Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 11/27/2024
- Location
- Winter Haven, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5010 units
Reason for Recall
The devices were inadvertently shipped after their expiration date.
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
Distribution Pattern
US: Massachusetts and Arkansas OUS: None
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.