{
  "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": "168755",
      "product_res_number": "Z-0516-2019",
      "event_date_initiated": "2018-10-09",
      "event_date_created": "2018-11-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-08-05",
      "res_event_number": "81451",
      "product_code": "KPO",
      "k_numbers": [
        "K030497"
      ],
      "product_description": "Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL\nCatalog Number: OFD2201-3B for hemodialysis",
      "code_info": "Lot code:18ETGF005",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Renal Therapies Group, LLC",
      "address_1": "920 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "reason_for_recall": "Discolored powder has confirmed the presence of a foreign substance",
      "root_cause_description": "Under Investigation by firm",
      "action": "Fresenius issued on 10/9/18  via Certified Mail An Urgent Medical Device Recall Customer Notification to affected consignees asking the consignees to check their stock immediately. If they have any listed GranuFlo Dry Acid Concentrate lot. numbers discontinue use immediately and place the product in a secure, segregated area.\nThe Urgent Medical Device Recall Customer Notification ask for the return of the affected lots and to contact Stericycle on instructions how to return the recalled lots. Contact Stericycle at 1-888-671-8851 for instructions on how to return the recalled product. This is EVENT# 10021.",
      "product_quantity": "4752",
      "distribution_pattern": "Distribution US nationwide and Mexico",
      "openfda": {
        "k_number": [
          "K202508",
          "K903835",
          "K823103",
          "K792513",
          "K253462",
          "K072908",
          "K800624",
          "K893991",
          "K865078",
          "K922088",
          "K810527",
          "K832866",
          "K171015",
          "K191474",
          "K820150",
          "K880102",
          "K872857",
          "K971053",
          "K891159",
          "K233213",
          "K193155",
          "K033386",
          "K131611",
          "K813586",
          "K050827",
          "K941958",
          "K011368",
          "K013655",
          "K030497",
          "K062399",
          "K982813",
          "K884725",
          "K180679",
          "K212052",
          "K041428",
          "K993212",
          "K834538",
          "K020230",
          "K090002",
          "K810925",
          "K020231",
          "K905021",
          "K843866",
          "K013724",
          "K072760",
          "K022500",
          "K243786",
          "K861156",
          "K010760",
          "K034066",
          "K120333",
          "K071387",
          "K990507",
          "K233950",
          "K870979",
          "K000792",
          "K233159",
          "K150966",
          "K781967",
          "K223431",
          "K052393",
          "K810280",
          "K896111",
          "K940601",
          "K821304",
          "K904946",
          "K191093",
          "K980659",
          "K813388",
          "K883068",
          "K852955",
          "K240920",
          "K070177",
          "K053286",
          "K160847",
          "K130511",
          "K973253",
          "K212620",
          "K162716",
          "K981043",
          "K120005",
          "K131202",
          "K851431",
          "K891921",
          "K981003",
          "K983618",
          "K854206",
          "K864265",
          "K922005",
          "K052253",
          "K042045",
          "K982378",
          "K864942",
          "K171750",
          "K192017",
          "K901472",
          "K252180",
          "K954527",
          "K001059",
          "K901471",
          "K221652",
          "K823779",
          "K863631",
          "K922990",
          "K013448",
          "K792213",
          "K022913",
          "K811706",
          "K895199",
          "K162887",
          "K012547",
          "K780353",
          "K910319",
          "K023985",
          "K102194",
          "K990010",
          "K192209",
          "K012328",
          "K022521",
          "K041683",
          "K901473",
          "K911459",
          "K910270"
        ],
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "1651896",
          "3005578748",
          "3003464075",
          "3013546115",
          "3007137482",
          "3019131",
          "2029275",
          "1652176",
          "1225714",
          "3035708507",
          "3013764800",
          "3027241826",
          "1056186",
          "3032828299",
          "2431908",
          "3038195011",
          "3027592507",
          "9610270",
          "3003591774",
          "3003768032",
          "1835498",
          "1954315",
          "8030639",
          "1528807",
          "3010242164",
          "3043014136",
          "3012364195",
          "9616277",
          "3004176176",
          "9611823",
          "3005162618",
          "3016096143",
          "9610725",
          "2183415"
        ],
        "fei_number": [
          "3002807005",
          "3005578748",
          "3003310249",
          "3003464075",
          "3001236991",
          "3013546115",
          "3007137482",
          "3003244997",
          "1000132332",
          "3003463852",
          "1000306431",
          "1000142899",
          "3035708507",
          "3013764800",
          "3027241826",
          "3032828299",
          "2183415",
          "2431908",
          "3038195011",
          "3027592507",
          "3003591774",
          "3002970979",
          "3012394756",
          "3006475063",
          "1527681",
          "3010242164",
          "6898",
          "3043014136",
          "3012364195",
          "3013942511",
          "405",
          "3004176176",
          "3016096143",
          "3001451489"
        ]
      }
    }
  ]
}