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U.S. Department of Health and Human Services

Class 2 Device Recall 3B Medical, Inc.

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 Class 2 Device Recall 3B Medical, Inc.see related information
Date Initiated by FirmNovember 27, 2024
Date PostedJanuary 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0828-2025
Recall Event ID 95918
Product Classification Catheter, nasal, oxygen - Product Code BZB
ProductBrand 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
Code Information Lot Code: Lot Number 20170403
Recalling Firm/
Manufacturer		 3B Medical, Inc.
203 Avenue A Nw Ste 300
Winter Haven FL 33881-4540
For Additional Information ContactChristopher Wood
+1-863-2259207
Manufacturer Reason
for Recall		The devices were inadvertently shipped after their expiration date.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce5010 units
DistributionUS: Massachusetts and Arkansas OUS: None
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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