{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "49877",
      "product_res_number": "Z-0583-2007",
      "event_date_initiated": "2007-01-02",
      "event_date_posted": "2007-03-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-02-24",
      "res_event_number": "37079",
      "product_code": "DWE",
      "k_numbers": [
        "K800178",
        "K891687"
      ],
      "product_description": "Medtronic 2T10R1 Intersept Custom Tubing Pack.    Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped.  The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end.  Tubing is used in the vent roller heads of the heart lung machine.  This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.",
      "code_info": "Lot 5666215",
      "firm_fei_number": "1000116158",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "city": "Brooklyn Park",
      "state": "MN",
      "postal_code": "55428-1088",
      "reason_for_recall": "One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled.  The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.",
      "root_cause_description": "Other",
      "action": "There was only one customer.  The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.",
      "product_quantity": "17",
      "distribution_pattern": "Illinois",
      "openfda": {
        "k_number": [
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          "K894721",
          "K092486",
          "K142607",
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          "K905686",
          "K150542",
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          "K993189",
          "K022857",
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          "K233702",
          "K810924",
          "K841959",
          "K993062",
          "K800178",
          "K803277"
        ],
        "registration_number": [
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          "1000523114",
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          "3009380063",
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        ],
        "device_name": "Tubing, Pump, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4390",
        "device_class": "2"
      }
    }
  ]
}