{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "34996",
      "product_res_number": "Z-0017-05",
      "event_date_initiated": "2004-09-20",
      "event_date_posted": "2004-10-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-06-28",
      "res_event_number": "30007",
      "product_code": "KDJ",
      "k_numbers": [
        "K822550"
      ],
      "product_description": "Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile\nwith Female Safe Lock Connector Luer Lock and Slide Clamp\n\nCatalog Number: 050-30034",
      "code_info": "Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care North America",
      "address_1": "95 Hayden Ave",
      "city": "Lexington",
      "state": "MA",
      "postal_code": "02421-7942",
      "additional_info_contact": "Arthur Ellinsfeld\n781-402-9068",
      "reason_for_recall": "Peritoneal Dialysis Transfer Set may have occluded pathway",
      "root_cause_description": "Other",
      "action": "Fresenius Medical is conducting telephone contact to the dialysis clinics starting 9/20/04 and follow-up with a notice to be mailed o/a 9/27/04.Clinics are requested to examine inventory for lot numbers and return unused product to Fresenius.",
      "product_quantity": "3,510 units",
      "distribution_pattern": "Nationwide\nCanada: Fresenius Medical Care  Canada 258 East Pearce Street, Richmond Hill, ON",
      "openfda": {
        "k_number": [
          "K801193",
          "K945567",
          "K780957",
          "K963668",
          "K930843",
          "K173593",
          "K192705",
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          "K792651",
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          "K083542",
          "K810671",
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          "K900142",
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          "K900012",
          "K151620",
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          "K892870",
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          "K900242",
          "K811863",
          "K781755",
          "K152129",
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          "K812771",
          "K214016",
          "K900006",
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          "K896956",
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          "K903869",
          "K921052",
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          "K870145",
          "K871155",
          "K895992",
          "K810600",
          "K801881",
          "K152675",
          "K900295",
          "K031676",
          "K852678",
          "K871050",
          "K173651",
          "K893231",
          "K972731",
          "K896599"
        ],
        "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2",
        "registration_number": [
          "3013188547",
          "1225714",
          "8030639",
          "3002907620",
          "2314912",
          "3038195011",
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          "3005941719",
          "3032828299",
          "1019003",
          "9611823",
          "3039353681",
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        ],
        "fei_number": [
          "3013188547",
          "1000219637",
          "3002807005",
          "3002681132",
          "3001236277",
          "3002807744",
          "3002907620",
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    }
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}