{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "65587",
      "product_res_number": "Z-0477-2008",
      "event_date_initiated": "2007-10-01",
      "event_date_posted": "2008-01-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-10-23",
      "res_event_number": "45485",
      "product_code": "DTN",
      "k_numbers": [
        "K930154"
      ],
      "product_description": "Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804",
      "code_info": "Lot Numbers 8763774, 8763791 and 8763782 (Model Number EL240)",
      "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": "763-391-9000",
      "reason_for_recall": "Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion  Blood Collection Reservoirs contain components made from an unapproved resin",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Medtronic sales force was notified and initiated calls with cutomers on 10/1/07.  Additionally, certified  Urgent Medical Device Recall letters dated 10/5/2007,  were sent to the 32 customers.  The letter explained the situaiton and requested that the impacted product  be returned for replacement or credit.  Medtronic is assessing patient use risks and will report those when determined.  Standard post-surgical monitoring is advised at the present by Medtronic .",
      "product_quantity": "413",
      "distribution_pattern": "Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and  AR.",
      "openfda": {
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        "device_name": "Reservoir, Blood, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4400",
        "device_class": "2"
      }
    }
  ]
}