Recall Z-0828-2025 ยท BZB Catheter, Nasal, Oxygen
3B Medical, Inc.
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
| Date | Jan 8, 2025 (initiated Nov 27, 2024) |
| Status | Open, Classified |
| Reason | The devices were inadvertently shipped after their expiration date. |
| Root cause | Nonconforming Material/Component |
| Action | On November 27, 2024 3B Medical Inc., dba React Health issued a "Urgent: Medical Device Recall" notification to affected consignees via Email. On 12/5/2024 React Health provided an updated letter to affected consignees via USPS certified Mail. In addition to making the aware of the issue, React Health asked consignees to take the following steps: 1. Please confirm receipt of this notification letter by returning the enclosed Customer Response Form to 3B Medical, Inc., within 7 days, by US Mail or via attachment to e-Mail sent to christopher.wood@reacthealth.com. 2. Confirm that end user |
| Quantity | 5010 units |
| Distribution | US: Massachusetts and Arkansas OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.