{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "136307",
      "product_res_number": "Z-1827-2015",
      "event_date_initiated": "2015-05-20",
      "event_date_posted": "2015-06-22",
      "recall_status": "Open, Classified",
      "res_event_number": "71160",
      "product_code": "KPO",
      "k_numbers": [
        "K071387"
      ],
      "product_description": "NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle\nCatalog Number: 08-4000-LB\nThis concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.",
      "code_info": "Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "800-662-1237",
      "reason_for_recall": "Bacterial contamination.",
      "root_cause_description": "Process control",
      "action": "Fresenius Medical Care sent an Urgent Medical Device Recall letter dated May 15, 2015, to all affected customers.   Users were requested to Immediately examine stock to determine whether  they have any Naturalyte Liquid Bicarbonate Concentrate of the lots.\n\" If any product of these lots is found, discontinue use immediately.\n\" Place all units in a secure, segregated area.\n\" If affected product was on the machine prior to patient treatment, perform a\n[Heat Disinfect] program.\n\" Your dialysis schedule should not be interrupted. If interruption of your\ndialysis schedule is expected, please discuss your options with your health\ncare provider.\n\" Contact  FMCNA Customer Service Team at 1-800-323-5188 for\ninstructions on how to return the recalled product.\n\" Promptly fill out and return the attached reply form\nAdditional medical concerns or questions, please contact Medical Information\nand Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.\nFor questions regarding this recall call 800-662-1237.",
      "product_quantity": "1,856,619 Bottles",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K792513",
          "K131611",
          "K810280",
          "K240920",
          "K896111",
          "K980659",
          "K130511",
          "K820150",
          "K954527",
          "K834538",
          "K022500",
          "K981043",
          "K010760",
          "K901473",
          "K973253",
          "K810527",
          "K781967",
          "K813586",
          "K090002",
          "K171015",
          "K910319",
          "K864942",
          "K891921",
          "K000792",
          "K990507",
          "K993212",
          "K810925",
          "K982813",
          "K832866",
          "K034066",
          "K901471",
          "K070177",
          "K843866",
          "K864265",
          "K071387",
          "K180679",
          "K001059",
          "K800624",
          "K243786",
          "K013655",
          "K072760",
          "K022521",
          "K884725",
          "K020231",
          "K171750",
          "K861156",
          "K041683",
          "K120333",
          "K192017",
          "K922088",
          "K052253",
          "K160847",
          "K922990",
          "K260799",
          "K865078",
          "K893991",
          "K870979",
          "K162887",
          "K823103",
          "K041428",
          "K903835",
          "K033386",
          "K922005",
          "K901472",
          "K011368",
          "K233213",
          "K813388",
          "K062399",
          "K162716",
          "K253462",
          "K102194",
          "K891159",
          "K150966",
          "K013448",
          "K212052",
          "K191093",
          "K192209",
          "K863631",
          "K120005",
          "K223431",
          "K022913",
          "K020230",
          "K895199",
          "K880102",
          "K252180",
          "K191474",
          "K941958",
          "K212620",
          "K905021",
          "K023985",
          "K042045",
          "K030497",
          "K883068",
          "K233950",
          "K981003",
          "K983618",
          "K221652",
          "K072908",
          "K202508",
          "K971053",
          "K792213",
          "K911459",
          "K780353",
          "K050827",
          "K052393",
          "K013724",
          "K823779",
          "K053286",
          "K940601",
          "K811706",
          "K233159",
          "K131202",
          "K851431",
          "K852955",
          "K012328",
          "K193155",
          "K982378",
          "K854206",
          "K990010",
          "K910270",
          "K821304",
          "K012547",
          "K904946",
          "K872857"
        ],
        "registration_number": [
          "2029275",
          "1954315",
          "2183415",
          "9610725",
          "1651896",
          "3038195011",
          "2431908",
          "1225714",
          "9611823",
          "3003591774",
          "3003464075",
          "3043014136",
          "3007137482",
          "1056186",
          "1528807",
          "3005578748",
          "9610270",
          "3032828299",
          "1835498",
          "3013764800",
          "3003768032",
          "3004176176",
          "3035708507",
          "3005162618",
          "3027241826",
          "9616277",
          "3016096143",
          "8030639",
          "3019131",
          "3013546115",
          "3027592507",
          "3012364195",
          "3010242164",
          "1652176"
        ],
        "fei_number": [
          "405",
          "2183415",
          "3002970979",
          "3001236991",
          "3003463852",
          "3001451489",
          "1000132332",
          "3038195011",
          "2431908",
          "3003310249",
          "3003591774",
          "3003464075",
          "3002807005",
          "3043014136",
          "3003244997",
          "6898",
          "1527681",
          "3007137482",
          "3005578748",
          "3032828299",
          "3012394756",
          "1000306431",
          "3006475063",
          "3013764800",
          "3004176176",
          "3035708507",
          "1000142899",
          "3027241826",
          "3016096143",
          "3013942511",
          "3013546115",
          "3027592507",
          "3012364195",
          "3010242164"
        ],
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
      }
    }
  ]
}