{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "161062",
      "product_res_number": "Z-0664-2018",
      "event_date_initiated": "2017-12-19",
      "event_date_created": "2018-02-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-08-11",
      "res_event_number": "79000",
      "product_code": "DWE",
      "k_numbers": [
        "K981613"
      ],
      "product_description": "Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx.  The firm name on the label is Sorin Group USA, Inc., Arvada, CO.",
      "code_info": "Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071",
      "firm_fei_number": "1718850",
      "recalling_firm": "LivaNova USA",
      "address_1": "14401 W 65th Way",
      "city": "Arvada",
      "state": "CO",
      "postal_code": "80004-3503",
      "additional_info_contact": "Joan Ceasar\n281-228-7260",
      "reason_for_recall": "The product is labeled with the incorrect expiration date.",
      "root_cause_description": "Process control",
      "action": "The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.",
      "product_quantity": "16 units (6 from lot 1717800062 and 10 units from lot 1720800071",
      "distribution_pattern": "Distribution was made to one consignee in LA.",
      "openfda": {
        "k_number": [
          "K841959",
          "K013578",
          "K842044",
          "K993062",
          "K923231",
          "K803277",
          "K142607",
          "K902845",
          "K894721",
          "K993189",
          "K905686",
          "K053025",
          "K092486",
          "K022857",
          "K981613",
          "K080592",
          "K801394",
          "K810924",
          "K800178",
          "K150542",
          "K233702"
        ],
        "registration_number": [
          "3017987980",
          "2011171",
          "3015537049",
          "3019807891",
          "2520313",
          "1718850",
          "2029275",
          "1000523114",
          "9617601",
          "1043214",
          "1721676",
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          "1724474",
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          "1124841",
          "1222928",
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          "3005941719",
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        "fei_number": [
          "3017987980",
          "1000116158",
          "2011171",
          "3015537049",
          "3019807891",
          "2520313",
          "1718850",
          "3000204839",
          "1000523114",
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          "3002534070",
          "1043214",
          "1721676",
          "3003094851",
          "1928237",
          "1000120613",
          "3009380063",
          "3002807111",
          "1319211",
          "3044156918"
        ],
        "device_name": "Tubing, Pump, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4390",
        "device_class": "2"
      }
    }
  ]
}