{
  "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": "138829",
      "product_res_number": "Z-2373-2015",
      "event_date_initiated": "2015-07-16",
      "event_date_posted": "2015-08-12",
      "recall_status": "Open, Classified",
      "res_event_number": "71724",
      "product_code": "KPO",
      "k_numbers": [
        "K071387"
      ],
      "product_description": "Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle\nA Dialysate Concentrate for Hemodialysis (liquid)\nProduct Code: 08-4000-LB",
      "code_info": "Lots begin with: 15AMLB, 15BMLB, 15CMLB.",
      "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": "SAME\n800-662-1237",
      "reason_for_recall": "Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.",
      "root_cause_description": "Process control",
      "action": "Fresenius Medical NA issued an Urgent Expanded Medical Device Recall letter on 7/16/15 to clinics and patients.  The letter identified the affected product, explained the reason for the expansion, and instructed users to immediately examine their stock to determine whether there was any Naturalyte Liquid Bicarbonate Concentrate beginning with 15AMLB, 15BMLB, 15CMLB.\nUsers are to discontinue use immediately if any product of these lots is found, .\nAll units are to be placed in a secure, segregated area.\nIf affected product was on the machine prior to patient treatment, a [Heat Disinfect] program should be performed.\nThe attached Reply Form should be completed and returned.\nContact your FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.",
      "product_quantity": "2,264,028",
      "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",
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          "K832866",
          "K034066",
          "K901471",
          "K070177",
          "K843866",
          "K864265",
          "K071387",
          "K180679",
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          "K800624",
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          "K884725",
          "K020231",
          "K171750",
          "K861156",
          "K041683",
          "K120333",
          "K192017",
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          "K052253",
          "K160847",
          "K922990",
          "K260799",
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          "K893991",
          "K870979",
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          "K880102",
          "K252180",
          "K191474",
          "K941958",
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          "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",
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          "3019131",
          "3013546115",
          "3027592507",
          "3012364195",
          "3010242164",
          "1652176"
        ],
        "fei_number": [
          "405",
          "2183415",
          "3002970979",
          "3001236991",
          "3003463852",
          "3001451489",
          "1000132332",
          "3038195011",
          "2431908",
          "3003310249",
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          "3002807005",
          "3043014136",
          "3003244997",
          "6898",
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          "3005578748",
          "3032828299",
          "3012394756",
          "1000306431",
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          "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"
      }
    }
  ]
}