{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "194414",
      "product_res_number": "Z-1370-2022",
      "event_date_initiated": "2022-05-31",
      "event_date_created": "2022-07-12",
      "recall_status": "Open, Classified",
      "res_event_number": "90438",
      "product_code": "KPO",
      "k_numbers": [
        "K192017"
      ],
      "product_description": "NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure\nPart Number: 08-2251-0",
      "code_info": "UDI-DI: (01) 000840861101696               (17) 240331               (10) 22CTAC106  Lot Number: 22CTAC106 Exp Date: 2024-03-31",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "SAME\n781-6999580",
      "reason_for_recall": "Alternate Bottle Caps labeled with \"Sealed for your Protection\" on the foil not qualified for use",
      "root_cause_description": "Under Investigation by firm",
      "action": "Fresenius Medical Care issued Urgent Medical Device Recall letter (FA-2022-11-T) dated 6/2/22. Letter states reason for recall, health risk and action to take:\nThese instructions apply only to clinics directly contacted by the Fresenius Medical Care Corrections and Removals Department.\n\" Immediately examine your stock to determine whether you have NaturaLyte Liquid Acid concentrate with the part and lot numbers listed below.\n\" Only bottles with  sealed for your protection  on the bottle cap foil are affected (see picture below).\n\" Remove the affected product from your inventory.\n\" FMCRTG, LLC will contact you regarding product return.\nPlease contact FMCRTG Customer Service at 1-800-323-5188 if you have any further questions.",
      "product_quantity": "656 cases",
      "distribution_pattern": "Natiowide",
      "openfda": {
        "k_number": [
          "K233159",
          "K870979",
          "K901473",
          "K990010",
          "K050827",
          "K865078",
          "K212052",
          "K020230",
          "K954527",
          "K983618",
          "K052393",
          "K022913",
          "K941958",
          "K990507",
          "K253462",
          "K810527",
          "K810280",
          "K042045",
          "K864265",
          "K001059",
          "K922990",
          "K041428",
          "K000792",
          "K813388",
          "K013655",
          "K993212",
          "K895199",
          "K982813",
          "K022521",
          "K150966",
          "K202508",
          "K171015",
          "K820150",
          "K896111",
          "K130511",
          "K131202",
          "K981043",
          "K053286",
          "K872857",
          "K012547",
          "K901471",
          "K070177",
          "K810925",
          "K852955",
          "K052253",
          "K981003",
          "K252180",
          "K780353",
          "K904946",
          "K191474",
          "K012328",
          "K823103",
          "K193155",
          "K191093",
          "K884725",
          "K072760",
          "K792213",
          "K013448",
          "K221652",
          "K023985",
          "K013724",
          "K243786",
          "K162716",
          "K864942",
          "K090002",
          "K260799",
          "K233950",
          "K940601",
          "K162887",
          "K854206",
          "K180679",
          "K800624",
          "K883068",
          "K781967",
          "K120333",
          "K192017",
          "K851431",
          "K922005",
          "K813586",
          "K792513",
          "K020231",
          "K102194",
          "K823779",
          "K891159",
          "K033386",
          "K971053",
          "K072908",
          "K030497",
          "K233213",
          "K922088",
          "K041683",
          "K861156",
          "K843866",
          "K120005",
          "K160847",
          "K863631",
          "K834538",
          "K062399",
          "K010760",
          "K131611",
          "K022500",
          "K034066",
          "K973253",
          "K171750",
          "K011368",
          "K192209",
          "K911459",
          "K905021",
          "K980659",
          "K893991",
          "K982378",
          "K240920",
          "K903835",
          "K910319",
          "K880102",
          "K821304",
          "K223431",
          "K811706",
          "K212620",
          "K910270",
          "K071387",
          "K832866",
          "K901472",
          "K891921"
        ],
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "1652176",
          "9610270",
          "3019131",
          "9610725",
          "3003464075",
          "3003591774",
          "1835498",
          "3007137482",
          "1056186",
          "3038195011",
          "1225714",
          "1954315",
          "3027241826",
          "3013546115",
          "3035708507",
          "8030639",
          "2431908",
          "3043014136",
          "9611823",
          "1651896",
          "1528807",
          "3003768032",
          "3016096143",
          "9616277",
          "3010242164",
          "3005578748",
          "3012364195",
          "3013764800",
          "2183415",
          "3004176176",
          "3027592507",
          "2029275",
          "3032828299",
          "3005162618"
        ],
        "fei_number": [
          "3001236991",
          "6898",
          "3003310249",
          "3013942511",
          "3003244997",
          "3003464075",
          "3003591774",
          "3007137482",
          "3038195011",
          "1527681",
          "1000142899",
          "3012394756",
          "3027241826",
          "3013546115",
          "3035708507",
          "1000306431",
          "3001451489",
          "2431908",
          "3043014136",
          "3002807005",
          "1000132332",
          "3016096143",
          "3010242164",
          "3005578748",
          "3012364195",
          "3032828299",
          "3013764800",
          "3003463852",
          "2183415",
          "3004176176",
          "3027592507",
          "3002970979",
          "3006475063",
          "405"
        ]
      }
    }
  ]
}