{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "45473",
      "product_res_number": "Z-0834-06",
      "event_date_initiated": "2006-03-22",
      "event_date_posted": "2006-05-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-11",
      "res_event_number": "35184",
      "product_code": "FKX",
      "k_numbers": [
        "K002892"
      ],
      "product_description": "Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. \nCatalog Number: 050-87028",
      "code_info": "Lot Numbers: 5SR119; 52R124; 5SR125; 5SR149; 5SR150; 5SR173; 6AR014;  6AR015; 6AR032; 6AR044; 6AR045; 6AR055; 6AR069; 6AR085; 06AR086; 6AR267; 6AR280;6AR298; 6BR013;6BR031; 6BR040; 6BR043; 6BR064; 6BR075; 6BR091; 6BR092; 6BR110; 6BR127; 6BR141; 6BR281",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care North America",
      "address_1": "95 Hayden Avenue",
      "city": "Lexington",
      "state": "MA",
      "postal_code": "02421-7942",
      "additional_info_contact": "Arthur E. Eilinsfeld\n781-402-9009",
      "reason_for_recall": "Stay safe trigger body may not connect to the extension set and result in associated peritonitis",
      "root_cause_description": "Other",
      "action": "Fresenius Medical notified customers by telephone on 3/24/06 for initial lots recalled and followed by letter dated 3/30/06 to include all lots numbers recalled.",
      "product_quantity": "141,770 units",
      "distribution_pattern": "Nationwide\nCanada",
      "openfda": {
        "k_number": [
          "K830208",
          "K822025",
          "K823777",
          "K874632",
          "K820179",
          "K002892",
          "K823303",
          "K822548",
          "K250523",
          "K141145",
          "K822712",
          "K901228",
          "K810683",
          "K923065",
          "K831716",
          "K933687",
          "K823331",
          "K103220",
          "K830257",
          "K823390",
          "K833749",
          "K822546",
          "K124018",
          "K201867",
          "K842885",
          "K844630",
          "K823330",
          "K862928",
          "K844108",
          "K901478",
          "K884554",
          "K830881",
          "K220935",
          "K935659",
          "K811986",
          "K822550",
          "K151525",
          "K994218",
          "K822361",
          "K902149",
          "K012988",
          "K243371",
          "K822545",
          "K850406",
          "K102936",
          "K822547",
          "K905809",
          "K772150",
          "K771484",
          "K813487",
          "K053512",
          "K043363",
          "K823857",
          "K833595",
          "K842305",
          "K833065",
          "K830689",
          "K823217",
          "K212522",
          "K171652",
          "K910173",
          "K831766",
          "K822658",
          "K823827",
          "K901477",
          "K823296",
          "K173718",
          "K840224",
          "K845042",
          "K822549",
          "K841929",
          "K830766",
          "K895336",
          "K872652",
          "K822543",
          "K791342",
          "K822544",
          "K222318",
          "K844144",
          "K212658",
          "K181108",
          "K123630",
          "K832141"
        ],
        "registration_number": [
          "8030638",
          "",
          "9612057",
          "9612052",
          "3031565407",
          "3006755813",
          "2132111",
          "3012494290",
          "3010421104",
          "3039353681",
          "3003865400",
          "3033589330",
          "3012536737",
          "3015882716",
          "3038277270",
          "9680579",
          "1225714",
          "3030306055",
          "3002907620",
          "3004111573",
          "3003537036",
          "3015309643",
          "1721504",
          "2314912",
          "3032828299",
          "3015225571",
          "1721676",
          "3015335038",
          "3038195011",
          "3006194679",
          "1319639",
          "3006950086",
          "1649518",
          "9610270",
          "2133641",
          "2030624",
          "1724474",
          "9680340",
          "8030665",
          "1650907",
          "3003504604"
        ],
        "fei_number": [
          "",
          "3031565407",
          "1000138054",
          "3006755813",
          "3001236277",
          "3012494290",
          "3010421104",
          "1000140026",
          "3039353681",
          "3003865400",
          "3033589330",
          "3012536737",
          "3015882716",
          "3038277270",
          "1000203464",
          "3002807744",
          "3002806727",
          "3030306055",
          "3002907620",
          "3004111573",
          "3003537036",
          "3015309643",
          "1721504",
          "2314912",
          "3002806443",
          "3032828299",
          "3000203466",
          "3015225571",
          "1721676",
          "3015335038",
          "3003094851",
          "3038195011",
          "3006194679",
          "3006950086",
          "3002806460",
          "3000206435",
          "3012394756",
          "3002681132",
          "3003504604",
          "1000434163",
          "3001451489"
        ],
        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}