{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Arvada",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78331",
      "recalling_firm": "Sorin Group USA, Inc.",
      "address_1": "14401 W 65th Way",
      "address_2": "N/A",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) Internationally to  France and Spain",
      "recall_number": "Z-0076-2018",
      "product_description": "FlexFlow Venous Cannula Model/Catalog Number 200-200  The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch",
      "product_quantity": "40 units",
      "reason_for_recall": "A specific lot of the FlexFlowTM Venous  Cannula, 200-200, is being recalled because it is sharper or pointier than expected.",
      "recall_initiation_date": "20170928",
      "center_classification_date": "20171108",
      "termination_date": "20181017",
      "report_date": "20171115",
      "code_info": "Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185"
    }
  ]
}