Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number:

FDA device recall Z-0828-2025 · posted 2025-01-08 · Open, Classified

Recall details

Recalling firm

3B Medical, Inc.

Reason for recall

The devices were inadvertently shipped after their expiration date.

Action taken

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 users and customers have been contacted and instructed to stop using the affected cannulas. 3. Return the affected product to 3B Medical, Inc. dba React Health. 3B Medical, Inc., dba React Health will provide FedEx return labels or arrange for the shipping of the devices you have to return. 4. 3B Medical, Inc., dba React Health, has inventory to replace your devices and will place $0 orders to replace all the devices that were shipped to you expired. 5. Please acknowledge receipt of this notification and respond via the enclosed Customer Response Form within 7 days of receipt. 6. Adverse events, reactions. or quality issues experienced with the use of these devices may be reported to us at 3B Medical, Inc., dba React Health or via the FDA s MedWatch Adverse Event Reporting program.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

BZB

Quantity affected

5010 units

Distribution

US: Massachusetts and Arkansas OUS: None

Date initiated

2024-11-27

Date posted

2025-01-08

Location

Winter Haven, FL