{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140768",
      "product_res_number": "Z-0194-2016",
      "event_date_initiated": "2015-10-06",
      "event_date_created": "2015-10-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-06-27",
      "res_event_number": "72362",
      "product_code": "KDJ",
      "k_numbers": [
        "K791899"
      ],
      "product_description": "Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path",
      "code_info": "H15C11095",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "Leakage from the inlet port of the 15L Cycler Drainage Bags.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\r\n\r\nThe recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.",
      "product_quantity": "19,440 units",
      "distribution_pattern": "US Distribution and Internationally to Canada.",
      "openfda": {
        "k_number": [
          "K895991",
          "K860230",
          "K895990",
          "K892870",
          "K173363",
          "K883393",
          "K900106",
          "K871583",
          "K896599",
          "K772236",
          "K870145",
          "K800993",
          "K921818",
          "K900242",
          "K031676",
          "K894783",
          "K781755",
          "K041792",
          "K912208",
          "K812772",
          "K811863",
          "K896600",
          "K173593",
          "K945567",
          "K780957",
          "K801220",
          "K900006",
          "K810600",
          "K892871",
          "K772136",
          "K882455",
          "K851208",
          "K813069",
          "K925403",
          "K904806",
          "K812771",
          "K042900",
          "K811294",
          "K900295",
          "K972579",
          "K882498",
          "K900004",
          "K920586",
          "K791512",
          "K895792",
          "K780082",
          "K895992",
          "K853550",
          "K893712",
          "K820546",
          "K900005",
          "K022412",
          "K920029",
          "K900012",
          "K851207",
          "K895673",
          "K250404",
          "K900142",
          "K152675",
          "K810671",
          "K900140",
          "K871154",
          "K903869",
          "K152129",
          "K812802",
          "K972731",
          "K900008",
          "K852678",
          "K791722",
          "K803300",
          "K902526",
          "K896761",
          "K896764",
          "K151620",
          "K902451",
          "K915628",
          "K870626",
          "K173651",
          "K871155",
          "K771482",
          "K124024",
          "K214016",
          "K921052",
          "K893231",
          "K900226",
          "K900243",
          "K895631",
          "K871050",
          "K892872",
          "K791426",
          "K812130",
          "K791899",
          "K883239",
          "K860700",
          "K231849",
          "K961825",
          "K083542",
          "K810840",
          "K896763",
          "K974387",
          "K963668",
          "K873984",
          "K915304",
          "K896956",
          "K801881",
          "K900141",
          "K900323",
          "K810670",
          "K792651",
          "K871049",
          "K801193",
          "K930843",
          "K192705"
        ],
        "registration_number": [
          "8030639",
          "8030665",
          "3038277270",
          "1650907",
          "1649518",
          "1019003",
          "3038195011",
          "2314912",
          "3013188547",
          "3016096143",
          "3005941719",
          "1225714",
          "3003504604",
          "3039353681",
          "9612168",
          "3032828299",
          "3002907620",
          "3015335038",
          "9680579",
          "9611823",
          "1058584",
          "3004111573",
          "3035708507"
        ],
        "fei_number": [
          "1000219637",
          "3001236277",
          "3038277270",
          "3002806471",
          "1019003",
          "3002681132",
          "3038195011",
          "2314912",
          "3013188547",
          "3002807005",
          "3002807744",
          "3016096143",
          "1000203464",
          "6898",
          "3003504604",
          "3002807111",
          "3039353681",
          "3001451489",
          "3032828299",
          "3002907620",
          "3015335038",
          "3004111573",
          "3035708507"
        ],
        "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}