{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Arvada",
      "state": "CO",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73126",
      "recalling_firm": "Sorin Group USA, Inc.",
      "address_1": "14401 W 65th Way",
      "address_2": "N/A",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution and Canada.",
      "recall_number": "Z-1018-2016",
      "product_description": "CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack.      Product Usage:  Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.",
      "product_quantity": "6859",
      "reason_for_recall": "The CDI System 500 monitor displays the \"H/S DISCONNECT AT CUVETTE\" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.",
      "recall_initiation_date": "20160119",
      "center_classification_date": "20160225",
      "termination_date": "20161024",
      "report_date": "20160302",
      "code_info": "Catalog Number 6922, 1/2 inch -lots TE27, TH06 and TK03  Catalog Number 6923, 3/8 inch - lots TE13, TE18, TG15, TH20 and TK17  b. Model Number(s): 020204612, 020208807, 020210805, 020211806, 020493806, 044002300, 044003200, 044004102, 044004700, 044010200, 044016900, 044017601, 044018700, 044019901, 044027700, 044035101, 075104103, 075104404, 020135802, 088511700, 084103204, 047000500, 046001601, 065255600, 066110500, 075203800, 627265002, 627304502, 084118101, 020277801, 075101900, 627309201, 075104800, 627138002, 627241801, 627305101, 627239301, 044006801, 627347601, 075203501, 627232601, 627123006, 627280901, 088523400, 627282602, 044022001, 627252001, 044020900, 627147304, 627147403, 627153904, 046003400, 627308201, 044013600, 088511801, 084515200, 044009000, 627282001, 044022000, 066109900, 627286901, 075201201, 075202000, 084103204, 088504901, 088508000, 088513300, 088513501, 627133104, 627139306, 627165604, 627166101, 627167301, 627167501, 627167601, 627167701, 627168001, 627168101, 627179903, 627190501, 627190801, 627197802, 627198001, 627198102, 627212201, 627297401, 047002300, 044000600, 627251001, 627254501, 627283501, 627283601, 627321201, 044003901, 088504400, 627198903, 627214003, 044028900, 627231801, 627240802, 627243501, 627243601, 627243701, 627244602, 627244701, 627246002, 627252001, 627256901, 627260701, 627262303, 627266301, 627269502, 627286802, 627286901, 627290001, 627303901, 627304901, 627336301, 627336402, 627343801, 627346601, 627346701, 627349401  Catalog Number 6924, 1/4 inch - lots TE20, TF11, TG01 , TG15, TH 13 and TH27",
      "more_code_info": ""
    }
  ]
}