{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-08",
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      "cfres_id": "211532",
      "product_res_number": "Z-0828-2025",
      "event_date_initiated": "2024-11-27",
      "event_date_posted": "2025-01-08",
      "recall_status": "Open, Classified",
      "res_event_number": "95918",
      "product_code": "BZB",
      "product_description": "Brand Name: 3B Medical, Inc.\nProduct Name: Ultrasoft Oxygen Cannula, 12 Foot\nModel / Catalog Number: O2U2012\nLot Number: 20170403\nProduct Description: Nasal Cannulas for use with Oxygen Concentrators",
      "code_info": "Lot Code: Lot Number 20170403",
      "firm_fei_number": "3009096682",
      "recalling_firm": "3B Medical, Inc.",
      "address_1": "203 Avenue A Nw Ste 300 203 Avenue A Nw",
      "address_2": "Ste 300",
      "city": "Winter Haven",
      "state": "FL",
      "postal_code": "33881-4540",
      "additional_info_contact": "Christopher Wood\n+1-863-2259207",
      "reason_for_recall": "The devices were inadvertently shipped after their expiration date.",
      "root_cause_description": "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. \n\n In addition to making the aware of the issue, React Health asked consignees to take the following steps:\n\n1. 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.\n\n2. Confirm that end users and customers have been contacted and instructed to stop using the affected cannulas.\n\n3. 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.\n\n4. 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.\n\n5. Please acknowledge receipt of this notification and respond via the enclosed Customer Response Form within 7 days of receipt.\n\n6. 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.",
      "product_quantity": "5010 units",
      "distribution_pattern": "US: Massachusetts and Arkansas \nOUS: None",
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        "medical_specialty_description": "Anesthesiology",
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