{
  "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": [
    {
      "country": "United States",
      "city": "Pittsburgh",
      "address_1": "240 Alpha Dr",
      "reason_for_recall": "The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.",
      "address_2": "",
      "product_quantity": "11 kits",
      "code_info": "Serial Number/UDI  141445/  (01)00814112020517(17)200825(11)190423(21)00141445,    141446/  (01)00814112020517(17)200825(11)190423(21)00141446,    141447/  (01)00814112020517(17)200825(11)190423(21)00141447,    141448/  (01)00814112020517(17)200825(11)190423(21)00141448,    141449/  (01)00814112020517(17)200825(11)190423(21)00141449,    141450/  (01)00814112020517(17)200825(11)190423(21)00141450,    141451/  (01)00814112020517(17)200825(11)190429(21)00141451,    141452/  (01)00814112020517(17)200825(11)190429(21)00141452,    141453/  (01)00814112020517(17)200825(11)190429(21)00141453,    141454/  (01)00814112020517(17)200825(11)190429(21)00141454,    141457/  (01)00814112020517(17)200825(11)190429(21)00141457    Expiration Date for all products - August 25, 2020",
      "center_classification_date": "20200207",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, AL, ME, LA, PA.",
      "state": "PA",
      "product_description": "TandemLife ECLS Procedure Kit - V24/A17, Catalog Number  5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.",
      "report_date": "20200219",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cardiac Assist, Inc",
      "recall_number": "Z-1106-2020",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "84611",
      "termination_date": "20201007",
      "more_code_info": "",
      "recall_initiation_date": "20191119",
      "postal_code": "15238-2906",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}