{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pittsburgh",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87632",
      "recalling_firm": "Cardiac Assist, Inc",
      "address_1": "240 Alpha Dr",
      "address_2": "N/A",
      "postal_code": "15238-2906",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, IL, TN.",
      "recall_number": "Z-1486-2021",
      "product_description": "Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization.   Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17  Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15  Catalog #: 5740-2417 - TandemLife Kit - V24/A17  Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)",
      "product_quantity": "13 kits",
      "reason_for_recall": "On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.",
      "recall_initiation_date": "20210319",
      "center_classification_date": "20210423",
      "termination_date": "20211122",
      "report_date": "20210505",
      "code_info": "LOT/SERIAL: 285586, 00145202, 00145204, 00871587, 00871549, 00871560, 00871561, 00871562, 00871563, 00871564, 00871565, 00871566, 00871567,     UDI:   (01) 00814112020463(17)231024(11)201024(10)285586  (01)00814112020517(17)220222(11)210118(21)00145202  (01)00814112020517(17)220222(11)210118(21)00145204  (01)00814112020708(17)210203(11)220117(21)00871587  (01)00814112020092(17)210129(11)220117(21)00871549  (01)00814112020092(17)210129(11)220117(21)00871560  (01)00814112020092(17)210129(11)220117(21)00871561  (01)00814112020092(17)210129(11)220117(21)00871562  (01)00814112020092(17)210129(11)220117(21)00871563  (01)00814112020092(17)210129(11)220117(21)00871564  (01)00814112020092(17)210129(11)220117(21)00871565  (01)00814112020092(17)210129(11)220117(21)00871566  (01)00814112020092(17)210129(11)220117(21)00871567",
      "more_code_info": ""
    }
  ]
}