{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "6000 Nathan Ln N",
      "reason_for_recall": "Certain models and lots of PORT A CATH implantable  port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.",
      "address_2": "",
      "product_quantity": "1,077 units total",
      "code_info": "a. Item No. 21-4474-24 (Lot No. 87X040, 87X117);    b. Item No. 21-4475-24 (Lot No. 87X044);    c. Item No. 21-4477-24 (Lot No. 87X097);    d. Item No. 21-8466-24 (Lot No. 87X171);    e. Item No. 21-8468-24 (Lot No. 87X172, 87X244, 87X180);    f.  Item No. 21-8469-24 (Lot No. 87X151);    g. Item No. 21-8470-24 (Lot No. 87X173, 87X254, 87X194, 87X198, 87X237)",
      "center_classification_date": "20180315",
      "distribution_pattern": "Worldwide Distribution.  US nationwide including Puerto Rico,  Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.",
      "state": "MN",
      "product_description": "Power PORT-A-CATH  II, TRAY POWER PAC II.  Labeled as:      a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA);    b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA);    c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA);    d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA);    e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA);    f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA);    g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)",
      "report_date": "20180321",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Smiths Medical ASD Inc.",
      "recall_number": "Z-1074-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79429",
      "termination_date": "20200612",
      "more_code_info": "",
      "recall_initiation_date": "20171204",
      "postal_code": "55442-1690",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}