{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217459",
      "product_res_number": "Z-1185-2026",
      "event_date_initiated": "2025-12-12",
      "event_date_posted": "2026-01-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98030",
      "product_code": "FKH",
      "k_numbers": [
        "K041636"
      ],
      "product_description": "Conductivity Standard Solution\nCatalog/Model Numbers:\n10001, 10011, 10021, 10032, 10040, 10040c, and 10041\n\nConductivity Standard Solutions are a secondary standard solution used for the\ncalibration of conductivity cells together with conductivity meters",
      "code_info": "Catalog/Model Numbers/ Lot Numbers / UDI codes:\n10001\t14250616-1019106  (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE\n10011\t14250616-1019107  (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE\n10040c\t50250624-1019120  (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE\n10040\t50250624-1019119  (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE\n10032\t14250616-1019108  (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE\n10041\t50250522-1018643  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE\n10041\t50250624-1019121  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE\n10021\t15F250603-1018834  (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE",
      "firm_fei_number": "3003145976",
      "recalling_firm": "NIPRO Technical Services, Inc.",
      "address_1": "3110 N Oakland Ste 101 3110 N Oakland",
      "address_2": "Ste 101",
      "city": "Mesa",
      "state": "AZ",
      "postal_code": "85215-1168",
      "additional_info_contact": "Jaclyn Maiorana\n480-517-4918",
      "reason_for_recall": "due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 12/12/2025, the firm mailed/emailed an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers informing them that specific lots of Conductivity Standard Solutions have been identified as not meeting specification requirements which potentially could result with inaccurate calibration leading to electrolyte imbalances consistent with hypo- or hypernatremia. \n\nCustomer are instructed to\"\n1. Immediately stop using the affected products\n2.Segregate and quarantine all affected units\n3. Return the affected product for replacement or dispose of the product \n\nFor questions associated with this recall or if further assistance is needed, contact Customer Service at 800-923-2486 or email sales@niprotechnical.com.",
      "product_quantity": "499 units",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.",
      "openfda": {
        "k_number": [
          "K863824",
          "K041636",
          "K191496",
          "K851362",
          "K032075",
          "K130100",
          "K033330",
          "K812622"
        ],
        "device_name": "Solution-Test Standard-Conductivity, Dialysis",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "3003884198",
          "2020976",
          "1720309",
          "3003145976"
        ],
        "fei_number": [
          "3003884198",
          "2020976",
          "1720309",
          "3003145976"
        ]
      }
    }
  ]
}