{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48433",
      "product_res_number": "Z-0340-2007",
      "event_date_initiated": "2006-09-13",
      "event_date_posted": "2007-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-02-03",
      "res_event_number": "36333",
      "product_code": "DWE",
      "k_numbers": [
        "K800178"
      ],
      "product_description": "Medtronic Intersept Custom Tubing Pack.  Do Not Reuse.  The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer.  Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user.  The tubing is made of polyvinyl chloride (PVC).  Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine.  Manufacturer:  Medtronic, Inc., Minneapolis, MN  55432-5604  USA.  Tube supplier:  Natvar (Tekni-Plex Co.), 19555 E. Arenth Ave., City of Industry, CA  91748.",
      "code_info": "The following Model / Lot Number are affected:  CB4W39R1 / 4876667; 0A84R2 / 4531036;  1708R18 / 4627100;  0V68R4 / 4212182;   1P07R6 / 4433014;   1P07R6 / 4678134;  2Y91R / 4628170;  2Y91R / 4800224;  2Y91R / 4902036;  CB0Q49R14 / 4800849;  4D87R2 / 4184927.",
      "firm_fei_number": "1000116158",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "city": "Brooklyn Park",
      "state": "MN",
      "postal_code": "55428-1088",
      "additional_info_contact": "Rick Leonard\n763-391-9167",
      "reason_for_recall": "An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs.  The wall thickness is undersized and does not meet specifications.",
      "root_cause_description": "Other",
      "action": "An Important Customer Notification, dated 09/06/06, was sent to affected customers.  The letter identifies the affected model and lot numbers.  Medtronic requests that affected product be returned.  A suplemental pack  can be built and shipped to the customer upon request.  Medtronic will replace all returned product.  A Recall Certificate is asked to be completed by customer and faxed to Medtronic.",
      "product_quantity": "146",
      "distribution_pattern": "Distributed in 6 states:  CA, FL, IL, IN, LA and TN",
      "openfda": {
        "k_number": [
          "K142607",
          "K053025",
          "K923231",
          "K905686",
          "K233702",
          "K013578",
          "K022857",
          "K080592",
          "K810924",
          "K150542",
          "K894721",
          "K800178",
          "K993062",
          "K841959",
          "K981613",
          "K842044",
          "K902845",
          "K801394",
          "K803277",
          "K993189",
          "K092486"
        ],
        "registration_number": [
          "3044156918",
          "3019807891",
          "1124841",
          "1319211",
          "1724474",
          "1718850",
          "1928237",
          "3009380063",
          "1000523114",
          "3015537049",
          "2520313",
          "3017987980",
          "2011171",
          "1043214",
          "1222928",
          "2029275",
          "3005941719",
          "2184009",
          "1721676",
          "9617601"
        ],
        "fei_number": [
          "3044156918",
          "3019807891",
          "3002534070",
          "1319211",
          "3000204839",
          "1000116158",
          "1718850",
          "3009380063",
          "1928237",
          "3003094851",
          "1000523114",
          "1000120613",
          "3015537049",
          "2520313",
          "3017987980",
          "2011171",
          "3002807111",
          "1043214",
          "1000306431",
          "1721676"
        ],
        "device_name": "Tubing, Pump, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4390",
        "device_class": "2"
      }
    }
  ]
}