{
  "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": "2026-10-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "157731",
      "product_res_number": "Z-2771-2017",
      "event_date_initiated": "2017-06-30",
      "event_date_posted": "2017-07-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-10-10",
      "res_event_number": "77717",
      "product_code": "DWC",
      "k_numbers": [
        "K052601"
      ],
      "product_description": "STOCKERT Heater-Cooler System 3T, 230 V",
      "code_info": "Item No. 16-02-83; Serial No. 16S11455-16S16509",
      "firm_fei_number": "1718850",
      "recalling_firm": "Sorin Group USA, Inc.",
      "address_1": "14401 W 65th Way",
      "city": "Arvada",
      "state": "CO",
      "postal_code": "80004-3503",
      "additional_info_contact": "Joan Ceasar\n800-986-4702",
      "reason_for_recall": "Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.",
      "root_cause_description": "Device Design",
      "action": "\"Consignees were sent a recall notification, dated 06/30/2017, via mail. Instructions included a recommendation from LivaNova to use its oxygenators, or other oxygenators that are equipped with compatible heat exchangers, to ensure that the permeability rate is within the prescribed allowable limits (ALs).  Depending on whether or not the oxygenator was from LivaNova, there were specific instructions to follow for each type and source.  \r\n\r\nConsignees were also instructed to complete and return the Confirmation Form.\r\n\r\nIf product was further distributed, the firm asks that further customers be notified of the recall and that customers contact the LivaNova Quality Assurance Team at usfsn@livanova.com. Questions regarding the recall can be directed to 800-986-4702 or 3T.US@livanova.com. Any adverse reactions are to be reported to FDA's MedWatch Adverse Event Reporting program.\"",
      "product_quantity": "7,546 units total",
      "distribution_pattern": "\"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY.  \r\n\r\nForeign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA.\"",
      "openfda": {
        "k_number": [
          "K140012",
          "K102147",
          "K810647",
          "K014016",
          "K873813",
          "K130300",
          "K220635",
          "K896975",
          "K191402",
          "K896972",
          "K896973",
          "K831677",
          "K001520",
          "K873699",
          "K896974",
          "K896393",
          "K841402",
          "K874927",
          "K031544",
          "K052601",
          "K883603",
          "K122813",
          "K212657",
          "K945720",
          "K896971",
          "K822874",
          "K893940",
          "K071521",
          "K003145",
          "K873924"
        ],
        "registration_number": [
          "9611109",
          "1649914",
          "1928237",
          "1828100",
          "3007899424",
          "1723241",
          "3001588119",
          "1516825",
          "1720929",
          "3006073153"
        ],
        "fei_number": [
          "3001665800",
          "3002808267",
          "1928237",
          "1828100",
          "1000517719",
          "3007899424",
          "3001588119",
          "1516825",
          "1720929",
          "3006073153"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}