{
  "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": "215850",
      "product_res_number": "Z-0409-2026",
      "event_date_initiated": "2025-08-28",
      "event_date_posted": "2025-10-29",
      "recall_status": "Open, Classified",
      "res_event_number": "97527",
      "product_code": "FKX",
      "k_numbers": [
        "K201867"
      ],
      "product_description": "Sharesource Connectivity Platform for Use with Homechoice Claria\n\nProduct Code 5CGM01\nsoftware versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)",
      "code_info": "UDI-DI 15413765545723\nsoftware versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)",
      "firm_fei_number": "3030306055",
      "recalling_firm": "Vantive US Healthcare LLC",
      "address_1": "1 Baxter Pkwy Bldg 6 1 Baxter Pkwy",
      "address_2": "Bldg 6",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Vantive customer service\n800-284-4060",
      "reason_for_recall": "Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.",
      "root_cause_description": "Software design",
      "action": "Clinics whose patients' programs were identified as being impacted by this issue were contacted by phone beginning 8/29/2025. Follow-up written notifications were sent out to all affected customers starting September 11, 2025.\n\nThe Sharesource Claria software fix has been deployed and no further actions need to be taken by facilities who did not have directly affected patients. Note: If you have received the previous direct notification regarding a patient at your clinic, please\nnote that Vantive will continue to be in touch with you regarding the next steps to correct those specific patient\nprograms.",
      "product_quantity": "1",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turkey, United Kingdom, Chile, and Colombia.",
      "openfda": {
        "k_number": [
          "K830208",
          "K822025",
          "K823777",
          "K874632",
          "K820179",
          "K002892",
          "K823303",
          "K822548",
          "K250523",
          "K141145",
          "K822712",
          "K901228",
          "K810683",
          "K923065",
          "K831716",
          "K933687",
          "K823331",
          "K103220",
          "K830257",
          "K823390",
          "K833749",
          "K822546",
          "K124018",
          "K201867",
          "K842885",
          "K844630",
          "K823330",
          "K862928",
          "K844108",
          "K901478",
          "K884554",
          "K830881",
          "K220935",
          "K935659",
          "K811986",
          "K822550",
          "K151525",
          "K994218",
          "K822361",
          "K902149",
          "K012988",
          "K243371",
          "K822545",
          "K850406",
          "K102936",
          "K822547",
          "K905809",
          "K772150",
          "K771484",
          "K813487",
          "K053512",
          "K043363",
          "K823857",
          "K833595",
          "K842305",
          "K833065",
          "K830689",
          "K823217",
          "K212522",
          "K171652",
          "K910173",
          "K831766",
          "K822658",
          "K823827",
          "K901477",
          "K823296",
          "K173718",
          "K840224",
          "K845042",
          "K822549",
          "K841929",
          "K830766",
          "K895336",
          "K872652",
          "K822543",
          "K791342",
          "K822544",
          "K222318",
          "K844144",
          "K212658",
          "K181108",
          "K123630",
          "K832141"
        ],
        "registration_number": [
          "8030638",
          "",
          "9612057",
          "9612052",
          "3031565407",
          "3006755813",
          "2132111",
          "3012494290",
          "3010421104",
          "3039353681",
          "3003865400",
          "3033589330",
          "3012536737",
          "3015882716",
          "3038277270",
          "9680579",
          "1225714",
          "3030306055",
          "3002907620",
          "3004111573",
          "3003537036",
          "3015309643",
          "1721504",
          "2314912",
          "3032828299",
          "3015225571",
          "1721676",
          "3015335038",
          "3038195011",
          "3006194679",
          "1319639",
          "3006950086",
          "1649518",
          "9610270",
          "2133641",
          "2030624",
          "1724474",
          "9680340",
          "8030665",
          "1650907",
          "3003504604"
        ],
        "fei_number": [
          "",
          "3031565407",
          "1000138054",
          "3006755813",
          "3001236277",
          "3012494290",
          "3010421104",
          "1000140026",
          "3039353681",
          "3003865400",
          "3033589330",
          "3012536737",
          "3015882716",
          "3038277270",
          "1000203464",
          "3002807744",
          "3002806727",
          "3030306055",
          "3002907620",
          "3004111573",
          "3003537036",
          "3015309643",
          "1721504",
          "2314912",
          "3002806443",
          "3032828299",
          "3000203466",
          "3015225571",
          "1721676",
          "3015335038",
          "3003094851",
          "3038195011",
          "3006194679",
          "3006950086",
          "3002806460",
          "3000206435",
          "3012394756",
          "3002681132",
          "3003504604",
          "1000434163",
          "3001451489"
        ],
        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}