{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brooklyn Park",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72550",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "address_2": "N/A",
      "postal_code": "55428-1088",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including US: AL, IL, IN, and WI.",
      "recall_number": "Z-0268-2016",
      "product_description": "Medtronic Perfusion Tubing Packs, Models TL7M64R3,  TL7P17R1 &  HY2W85R9, Sterilized using Ethylene Oxide.  The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.",
      "product_quantity": "496",
      "reason_for_recall": "This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.",
      "recall_initiation_date": "20151028",
      "center_classification_date": "20151112",
      "termination_date": "20160817",
      "report_date": "20151118",
      "code_info": "Model Lot Numbers      Lot Number  HY2W85R9                     209704344,209704345,209704346,                                            209704347,210010558                    TL7M64R3                       209789393  TL7P17R1                       209789333"
    }
  ]
}