{
  "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": "2026-08-27",
    "results": {
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      "cfres_id": "204279",
      "product_res_number": "Z-0484-2024",
      "event_date_initiated": "2023-09-29",
      "event_date_posted": "2023-12-02",
      "recall_status": "Open, Classified",
      "res_event_number": "93408",
      "product_code": "GBZ",
      "k_numbers": [
        "K831931"
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      "product_description": "Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.",
      "code_info": "UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.",
      "firm_fei_number": "3011175548",
      "recalling_firm": "Atrium Medical Corporation",
      "address_1": "40 Continental Blvd",
      "city": "Merrimack",
      "state": "NH",
      "postal_code": "03054-4332",
      "additional_info_contact": "603-880-1433",
      "reason_for_recall": "A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory  Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to.  Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.",
      "product_quantity": "2460 units (246 cases, 10 units/case)",
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        "device_name": "Catheter, Cholangiography",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4200",
        "device_class": "1"
      }
    }
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}