Device 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
Z-0828-2025
Product summary
- Firm
- 3B Medical, Inc.
- Event
- Event 95918
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5010 units
- Official record key
device-enforcement:Z-0828-2025
Official wording
Reason: The devices were inadvertently shipped after their expiration date.
Code information: Lot Code: Lot Number 20170403
Distribution pattern: US: Massachusetts and Arkansas OUS: None
Derived failure modes
-
Unknown
The devices were inadvertently shipped after their expiration date.