Recall Z-0828-2025— 3B Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by 3B Medical, Inc., initiated 2024-11-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- 3B Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-27
- Firm location
- Winter Haven, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.